List of Excipients in API temozolomide

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Excipients in NDA-approved (novel) drugs containing temozolomide

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Merck Sharp & Dohme LLC	TEMODAR	temozolomide	0085-3004	ALCOHOL
Merck Sharp & Dohme LLC	TEMODAR	temozolomide	0085-3004	AMMONIA
Merck Sharp & Dohme LLC	TEMODAR	temozolomide	0085-3004	ANHYDROUS LACTOSE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing temozolomide

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Company	Ingredient	NDC	Excipient
Lannett Company Inc	temozolomide	0527-1777	ALCOHOL
Lannett Company Inc	temozolomide	0527-1777	ALUMINUM OXIDE
Lannett Company Inc	temozolomide	0527-1777	ANHYDROUS CITRIC ACID
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for temozolomide

Excipient focus: ALCOHOL

temozolomide drug variants containing ALCOHOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing ALCOHOL

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
Areva Pharmaceuticals	temozolomide	59923-712
>Company	>Ingredient	>NDC

Excipient focus: ALUMINUM OXIDE

temozolomide drug variants containing ALUMINUM OXIDE

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing ALUMINUM OXIDE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: AMMONIA

temozolomide drug variants containing AMMONIA

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing AMMONIA

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS CITRIC ACID

temozolomide drug variants containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
>Company	>Ingredient	>NDC

temozolomide drug variants not containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS LACTOSE

temozolomide drug variants containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

temozolomide drug variants not containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
Nivagen Pharmaceuticals Inc	temozolomide	75834-132
>Company	>Ingredient	>NDC

Excipient focus: BUTYL ALCOHOL

temozolomide drug variants containing BUTYL ALCOHOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing BUTYL ALCOHOL

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
Camber Pharmaceuticals Inc	temozolomide	31722-411
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

temozolomide drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
>Company	>Ingredient	>NDC

temozolomide drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: D&C YELLOW NO. 10

temozolomide drug variants containing D&C YELLOW NO. 10

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
AvPAK	temozolomide	50268-761
>Company	>Ingredient	>NDC

temozolomide drug variants not containing D&C YELLOW NO. 10

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 1

temozolomide drug variants containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2

temozolomide drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Sandoz Inc	temozolomide	0781-2691
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
ANI Pharmaceuticals Inc	temozolomide	43975-252
>Company	>Ingredient	>NDC

Excipient focus: FD&C RED NO. 3

temozolomide drug variants containing FD&C RED NO. 3

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	temozolomide	68382-751
Zydus Lifesciences Limited	temozolomide	70771-1092
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C RED NO. 3

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: FD&C RED NO. 40

temozolomide drug variants containing FD&C RED NO. 40

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
AvPAK	temozolomide	50268-761
Amneal Pharmaceuticals LLC	temozolomide	65162-801
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C RED NO. 40

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 5

temozolomide drug variants containing FD&C YELLOW NO. 5

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Company	Ingredient	NDC
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C YELLOW NO. 5

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 6

temozolomide drug variants containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
AvPAK	temozolomide	50268-761
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

temozolomide drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Accord Healthcare Inc	temozolomide	16729-048
Physicians Total Care Inc	temozolomide	54868-5348
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE YELLOW

temozolomide drug variants containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Sandoz Inc	temozolomide	0781-2691
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
AvPAK	temozolomide	50268-761
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

temozolomide drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

temozolomide drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Rising Pharma Holdings Inc	temozolomide	16571-816
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

temozolomide drug variants containing GELATIN

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing GELATIN

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: ISOPROPYL ALCOHOL

temozolomide drug variants containing ISOPROPYL ALCOHOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing ISOPROPYL ALCOHOL

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

temozolomide drug variants containing MANNITOL

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
>Company	>Ingredient	>NDC

temozolomide drug variants not containing MANNITOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: METHYL ALCOHOL

temozolomide drug variants containing METHYL ALCOHOL

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
>Company	>Ingredient	>NDC

temozolomide drug variants not containing METHYL ALCOHOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 80

temozolomide drug variants containing POLYSORBATE 80

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Company	Ingredient	NDC
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing POLYSORBATE 80

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: POTASSIUM HYDROXIDE

temozolomide drug variants containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Accord Healthcare Inc	temozolomide	16729-048
Camber Pharmaceuticals Inc	temozolomide	31722-411
>Company	>Ingredient	>NDC

temozolomide drug variants not containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K30

temozolomide drug variants containing POVIDONE K30

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Company	Ingredient	NDC
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

temozolomide drug variants not containing POVIDONE K30

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

temozolomide drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
Rising Pharmaceuticals Inc	temozolomide	64980-333
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

temozolomide drug variants containing SHELLAC

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SHELLAC

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Rising Pharmaceuticals Inc	temozolomide	64980-333
Ascend Laboratories LLC	temozolomide	67877-537
>Company	>Ingredient	>NDC

Excipient focus: SILICA DIMETHYL SILYLATE

temozolomide drug variants containing SILICA DIMETHYL SILYLATE

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	temozolomide	31722-411
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SILICA DIMETHYL SILYLATE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

temozolomide drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
Camber Pharmaceuticals Inc	temozolomide	31722-411
Sun Pharmaceutical Industries Inc	temozolomide	47335-890
>Company	>Ingredient	>NDC

Excipient focus: SODIUM LAURYL SULFATE

temozolomide drug variants containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Accord Healthcare Inc	temozolomide	16729-048
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STARCH GLYCOLATE TYPE A CORN

temozolomide drug variants containing SODIUM STARCH GLYCOLATE TYPE A CORN

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Company	Ingredient	NDC
Rising Pharma Holdings Inc	temozolomide	16571-816
Sun Pharmaceutical Industries Inc	temozolomide	47335-890
Rising Pharmaceuticals Inc	temozolomide	64980-333
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SODIUM STARCH GLYCOLATE TYPE A CORN

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STARCH GLYCOLATE TYPE A POTATO

temozolomide drug variants containing SODIUM STARCH GLYCOLATE TYPE A POTATO

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Accord Healthcare Inc	temozolomide	16729-048
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SODIUM STARCH GLYCOLATE TYPE A POTATO

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Rising Pharma Holdings Inc	temozolomide	16571-816
Sun Pharmaceutical Industries Inc	temozolomide	47335-890
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STARCH GLYCOLATE TYPE B POTATO

temozolomide drug variants containing SODIUM STARCH GLYCOLATE TYPE B POTATO

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	temozolomide	68382-751
Zydus Lifesciences Limited	temozolomide	70771-1092
>Company	>Ingredient	>NDC

temozolomide drug variants not containing SODIUM STARCH GLYCOLATE TYPE B POTATO

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

temozolomide drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Nivagen Pharmaceuticals Inc	temozolomide	75834-132
>Company	>Ingredient	>NDC

Excipient focus: TARTARIC ACID

temozolomide drug variants containing TARTARIC ACID

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

temozolomide drug variants not containing TARTARIC ACID

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Nivagen Pharmaceuticals Inc	temozolomide	75834-132
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

temozolomide drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
>Company	>Ingredient	>NDC

temozolomide drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: WATER

temozolomide drug variants containing WATER

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Company	Ingredient	NDC
Merck Sharp & Dohme LLC	temozolomide	0085-3004
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	temozolomide	23155-774
Physicians Total Care Inc	temozolomide	54868-5348
>Company	>Ingredient	>NDC

temozolomide drug variants not containing WATER

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Company	Ingredient	NDC
Lannett Company Inc	temozolomide	0527-1777
Sandoz Inc	temozolomide	0781-2691
Rising Pharma Holdings Inc	temozolomide	16571-816
>Company	>Ingredient	>NDC

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