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Last Updated: December 15, 2024

List of Excipients in API varenicline

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Excipients in NDA-approved (novel) drugs containing varenicline

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Oyster Point Pharma	TYRVAYA	varenicline	73521-030	HYDROCHLORIC ACID
Oyster Point Pharma	TYRVAYA	varenicline	73521-030	SODIUM CHLORIDE
Oyster Point Pharma	TYRVAYA	varenicline	73521-030	SODIUM HYDROXIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing varenicline

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Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	varenicline	0378-5089	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Mylan Pharmaceuticals Inc	varenicline	0378-5089	CROSCARMELLOSE SODIUM
Mylan Pharmaceuticals Inc	varenicline	0378-5089	GLYCERYL DIBEHENATE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for varenicline

Excipient focus: ANHYDROUS DIBASIC CALCIUM PHOSPHATE

varenicline drug variants containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

varenicline drug variants not containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
Major Pharmaceuticals	varenicline tartrate	0904-7413
Indoco Remedies Limited	varenicline tartrate	14445-153
>Company	>Ingredient	>NDC

Excipient focus: BUTYLATED HYDROXYANISOLE

varenicline drug variants containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
Glenmark Pharmaceuticals Inc USA	varenicline tartrate	68462-893
>Company	>Ingredient	>NDC

varenicline drug variants not containing BUTYLATED HYDROXYANISOLE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

varenicline drug variants containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
>Company	>Ingredient	>NDC

varenicline drug variants not containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

varenicline drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	varenicline	70710-1613
Zydus Lifesciences Limited	varenicline	70771-1773
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
>Company	>Ingredient	>NDC

varenicline drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: CROSCARMELLOSE SODIUM

varenicline drug variants containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

varenicline drug variants not containing CROSCARMELLOSE SODIUM

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 1

varenicline drug variants containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline tartrate	50090-7182
>Company	>Ingredient	>NDC

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

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2

varenicline drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
Bryant Ranch Prepack	varenicline	72162-2219
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
>Company	>Ingredient	>NDC

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

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

varenicline drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
NorthStar RxLLC	varenicline tartrate	72603-476
>Company	>Ingredient	>NDC

varenicline drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE YELLOW

varenicline drug variants containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Lupin Pharmaceuticals Inc	varenicline	70748-126
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
A-S Medication Solutions	varenicline tartrate	50090-7182
>Company	>Ingredient	>NDC

varenicline drug variants not containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: GLYCERYL DIBEHENATE

varenicline drug variants containing GLYCERYL DIBEHENATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
>Company	>Ingredient	>NDC

varenicline drug variants not containing GLYCERYL DIBEHENATE

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

varenicline drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE

varenicline drug variants containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

varenicline drug variants not containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
Zydus Pharmaceuticals USA Inc	varenicline	70710-1613
Lupin Pharmaceuticals Inc	varenicline	70748-126
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE

varenicline drug variants containing HYPROMELLOSE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Ajanta Pharma USA Inc	varenicline tartrate	27241-173
>Company	>Ingredient	>NDC

varenicline drug variants not containing HYPROMELLOSE

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

varenicline drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

varenicline drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
Oyster Point Pharma	varenicline	73521-030
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSES

varenicline drug variants containing HYPROMELLOSES

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Company	Ingredient	NDC
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
AVALANCHE PHARMACEUTICAL LLC	varenicline tartrate	82582-485
>Company	>Ingredient	>NDC

varenicline drug variants not containing HYPROMELLOSES

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

varenicline drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	varenicline	70710-1613
Lupin Pharmaceuticals Inc	varenicline	70748-126
Zydus Lifesciences Limited	varenicline	70771-1773
>Company	>Ingredient	>NDC

varenicline drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: MALTODEXTRIN

varenicline drug variants containing MALTODEXTRIN

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Company	Ingredient	NDC
Lupin Pharmaceuticals Inc	varenicline	70748-126
Major Pharmaceuticals	varenicline tartrate	0904-7413
Indoco Remedies Limited	varenicline tartrate	14445-153
>Company	>Ingredient	>NDC

varenicline drug variants not containing MALTODEXTRIN

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

varenicline drug variants containing MANNITOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
>Company	>Ingredient	>NDC

varenicline drug variants not containing MANNITOL

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

Excipient focus: MICROCRYSTALLINE CELLULOSE 302

varenicline drug variants containing MICROCRYSTALLINE CELLULOSE 302

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Company	Ingredient	NDC
Leading Pharma LLC	varenicline tartrate	69315-402
>Company	>Ingredient	>NDC

varenicline drug variants not containing MICROCRYSTALLINE CELLULOSE 302

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

varenicline drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
Major Pharmaceuticals	varenicline tartrate	0904-7413
>Company	>Ingredient	>NDC

varenicline drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 400

varenicline drug variants containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Indoco Remedies Limited	varenicline tartrate	14445-153
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
Medley Pharmaceuticals Limited	varenicline tartrate	42934-104
>Company	>Ingredient	>NDC

varenicline drug variants not containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOLS

varenicline drug variants containing POLYETHYLENE GLYCOLS

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Company	Ingredient	NDC
Carilion Materials Management	varenicline tartrate	68151-4952
Carilion Materials Management	varenicline tartrate	68151-4953
>Company	>Ingredient	>NDC

varenicline drug variants not containing POLYETHYLENE GLYCOLS

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

varenicline drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Zydus Pharmaceuticals USA Inc	varenicline	70710-1613
Zydus Lifesciences Limited	varenicline	70771-1773
Pfizer Laboratories Div Pfizer Inc	varenicline tartrate	0069-0468
>Company	>Ingredient	>NDC

varenicline drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

varenicline drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

varenicline drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

varenicline drug variants containing SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

varenicline drug variants containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STEARYL FUMARATE

varenicline drug variants containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
Golden State Medical Supply Inc	varenicline	51407-755
>Company	>Ingredient	>NDC

varenicline drug variants not containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
Zydus Pharmaceuticals USA Inc	varenicline	70710-1613
Lupin Pharmaceuticals Inc	varenicline	70748-126
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

varenicline drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Major Pharmaceuticals	varenicline tartrate	0904-7413
Indoco Remedies Limited	varenicline tartrate	14445-153
Camber Pharmaceuticals Inc	varenicline tartrate	31722-678
>Company	>Ingredient	>NDC

varenicline drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: TALC

varenicline drug variants containing TALC

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Company	Ingredient	NDC
Lupin Pharmaceuticals Inc	varenicline	70748-126
ENDO USA Inc	varenicline tartrate	49884-155
A-S Medication Solutions	varenicline tartrate	50090-7182
>Company	>Ingredient	>NDC

varenicline drug variants not containing TALC

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

varenicline drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

varenicline drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
Rebel Distributors Corp	varenicline tartrate	21695-633
>Company	>Ingredient	>NDC

Excipient focus: TRIACETIN

varenicline drug variants containing TRIACETIN

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

varenicline drug variants not containing TRIACETIN

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Company	Ingredient	NDC
Lupin Pharmaceuticals Inc	varenicline	70748-126
Oyster Point Pharma	varenicline	73521-030
Rebel Distributors Corp	varenicline tartrate	21695-633
>Company	>Ingredient	>NDC

Excipient focus: WATER

varenicline drug variants containing WATER

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Company	Ingredient	NDC
Oyster Point Pharma	varenicline	73521-030
>Company	>Ingredient	>NDC

varenicline drug variants not containing WATER

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	varenicline	0378-5089
A-S Medication Solutions	varenicline	50090-6446
A-S Medication Solutions	varenicline	50090-6447
>Company	>Ingredient	>NDC

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