List of Excipients in API fluorouracil

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Excipients in NDA-approved (novel) drugs containing fluorouracil

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Bausch Health US LLC	EFUDEX	fluorouracil	0187-3202	EDETATE DISODIUM
Bausch Health US LLC	EFUDEX	fluorouracil	0187-3202	HYDROXYPROPYL CELLULOSE
Bausch Health US LLC	EFUDEX	fluorouracil	0187-3202	METHYLPARABEN
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing fluorouracil

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Company	Ingredient	NDC	Excipient
NORTHSTAR RX LLC	fluorouracil	16714-178	METHYLPARABEN
NORTHSTAR RX LLC	fluorouracil	16714-178	POLYSORBATE 60
NORTHSTAR RX LLC	fluorouracil	16714-178	PROPYLENE GLYCOL
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for fluorouracil

Excipient focus: ANHYDROUS CITRIC ACID

fluorouracil drug variants containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: BENZYL ALCOHOL

fluorouracil drug variants containing BENZYL ALCOHOL

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing BENZYL ALCOHOL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: BUTYLATED HYDROXYTOLUENE

fluorouracil drug variants containing BUTYLATED HYDROXYTOLUENE

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing BUTYLATED HYDROXYTOLUENE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: CARBOMER HOMOPOLYMER TYPE C

fluorouracil drug variants containing CARBOMER HOMOPOLYMER TYPE C

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing CARBOMER HOMOPOLYMER TYPE C

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: CETYL ALCOHOL

fluorouracil drug variants containing CETYL ALCOHOL

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Company	Ingredient	NDC
Rebel Distributors Corp	fluorouracil	21695-829
HILL DERMACEUTICALS INC	fluorouracil	28105-421
Mayne Pharma Inc	fluorouracil	51862-362
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing CETYL ALCOHOL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: DIMETHICONE

fluorouracil drug variants containing DIMETHICONE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing DIMETHICONE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: EDETATE DISODIUM

fluorouracil drug variants containing EDETATE DISODIUM

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Encube Ethicals Private Limited	fluorouracil	21922-041
Taro Pharmaceuticals USA Inc	fluorouracil	51672-4062
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing EDETATE DISODIUM

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: ETHYLHEXYL HYDROXYSTEARATE

fluorouracil drug variants containing ETHYLHEXYL HYDROXYSTEARATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing ETHYLHEXYL HYDROXYSTEARATE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: GLYCERIN

fluorouracil drug variants containing GLYCERIN

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing GLYCERIN

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: GLYCERYL MONOSTEARATE

fluorouracil drug variants containing GLYCERYL MONOSTEARATE

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing GLYCERYL MONOSTEARATE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: HYDROXYPROPYL CELLULOSE

fluorouracil drug variants containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Encube Ethicals Private Limited	fluorouracil	21922-041
Taro Pharmaceuticals USA Inc	fluorouracil	51672-4062
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing HYDROXYPROPYL CELLULOSE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: ISOPROPYL MYRISTATE

fluorouracil drug variants containing ISOPROPYL MYRISTATE

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing ISOPROPYL MYRISTATE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: METHYL GLUCETH-10

fluorouracil drug variants containing METHYL GLUCETH-10

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing METHYL GLUCETH-10

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: METHYL GLUCETH-20

fluorouracil drug variants containing METHYL GLUCETH-20

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing METHYL GLUCETH-20

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

fluorouracil drug variants containing METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: METHYLPARABEN

fluorouracil drug variants containing METHYLPARABEN

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing METHYLPARABEN

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
Accord Healthcare Inc	fluorouracil	16729-276
Sagent Pharmaceuticals	fluorouracil	25021-215
>Company	>Ingredient	>NDC

Excipient focus: MINERAL OIL

fluorouracil drug variants containing MINERAL OIL

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing MINERAL OIL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: PEANUT OIL

fluorouracil drug variants containing PEANUT OIL

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing PEANUT OIL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: PETROLATUM

fluorouracil drug variants containing PETROLATUM

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Accord Healthcare Inc	fluorouracil	16729-542
Rebel Distributors Corp	fluorouracil	21695-829
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing PETROLATUM

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 400

fluorouracil drug variants containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 4500

fluorouracil drug variants containing POLYETHYLENE GLYCOL 4500

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Company	Ingredient	NDC
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing POLYETHYLENE GLYCOL 4500

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 60

fluorouracil drug variants containing POLYSORBATE 60

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
NORTHSTAR RX LLC	fluorouracil	16714-178
Accord Healthcare Inc	fluorouracil	16729-542
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing POLYSORBATE 60

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 80

fluorouracil drug variants containing POLYSORBATE 80

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing POLYSORBATE 80

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

fluorouracil drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
Accord Healthcare Inc	fluorouracil	16729-276
Sagent Pharmaceuticals	fluorouracil	25021-215
>Company	>Ingredient	>NDC

Excipient focus: PROPYLPARABEN

fluorouracil drug variants containing PROPYLPARABEN

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing PROPYLPARABEN

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
Accord Healthcare Inc	fluorouracil	16729-276
Sagent Pharmaceuticals	fluorouracil	25021-215
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

fluorouracil drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Almirall LLC	fluorouracil	16110-812
Accord Healthcare Inc	fluorouracil	16729-276
Sagent Pharmaceuticals	fluorouracil	25021-215
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

Excipient focus: SORBITAN MONOOLEATE

fluorouracil drug variants containing SORBITAN MONOOLEATE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing SORBITAN MONOOLEATE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

fluorouracil drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
HILL DERMACEUTICALS INC	fluorouracil	28105-421
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: STEARYL ALCOHOL

fluorouracil drug variants containing STEARYL ALCOHOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
NORTHSTAR RX LLC	fluorouracil	16714-178
Accord Healthcare Inc	fluorouracil	16729-542
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing STEARYL ALCOHOL

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: TROLAMINE

fluorouracil drug variants containing TROLAMINE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Spear Dermatology Products Inc	fluorouracil	66530-258
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing TROLAMINE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

Excipient focus: TROMETHAMINE

fluorouracil drug variants containing TROMETHAMINE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Encube Ethicals Private Limited	fluorouracil	21922-041
Taro Pharmaceuticals USA Inc	fluorouracil	51672-4062
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing TROMETHAMINE

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
>Company	>Ingredient	>NDC

Excipient focus: WATER

fluorouracil drug variants containing WATER

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
Almirall LLC	fluorouracil	16110-812
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing WATER

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Mylan Pharmaceuticals Inc	fluorouracil	0378-8078
Sagent Pharmaceuticals	fluorouracil	25021-215
>Company	>Ingredient	>NDC

Excipient focus: WHITE PETROLATUM

fluorouracil drug variants containing WHITE PETROLATUM

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Company	Ingredient	NDC
NORTHSTAR RX LLC	fluorouracil	16714-178
Taro Pharmaceuticals USA Inc	fluorouracil	51672-4118
NuCare PharmaceuticalsInc	fluorouracil	68071-3489
>Company	>Ingredient	>NDC

fluorouracil drug variants not containing WHITE PETROLATUM

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Company	Ingredient	NDC
Bausch Health US LLC	fluorouracil	0187-3202
Bausch Health US LLC	fluorouracil	0187-5200
Mylan Pharmaceuticals Inc	fluorouracil	0378-4791
>Company	>Ingredient	>NDC

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