List of Excipients in API sodium phenylbutyrate

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Excipients in NDA-approved (novel) drugs containing sodium phenylbutyrate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Medunik USA	PHEBURANE	sodium phenylbutyrate	71770-100	ETHYLCELLULOSES
Medunik USA	PHEBURANE	sodium phenylbutyrate	71770-100	HYPROMELLOSE 2910
Medunik USA	PHEBURANE	sodium phenylbutyrate	71770-100	POLYETHYLENE GLYCOL 1500
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing sodium phenylbutyrate

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Company	Ingredient	NDC	Excipient
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086	CALCIUM STEARATE
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086	SILICON DIOXIDE
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006	CALCIUM STEARATE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for sodium phenylbutyrate

Excipient focus: ACACIA

sodium phenylbutyrate drug variants containing ACACIA

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing ACACIA

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: CALCIUM STEARATE

sodium phenylbutyrate drug variants containing CALCIUM STEARATE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing CALCIUM STEARATE

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
Horizon Therapeutics USA Inc	sodium phenylbutyrate	75987-060
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

sodium phenylbutyrate drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
Horizon Therapeutics USA Inc	sodium phenylbutyrate	75987-060
Par Pharmaceutical Inc	sodium phenylbutyrate tablets, 500 mg	49884-170
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
Medunik USA	sodium phenylbutyrate	71770-100
>Company	>Ingredient	>NDC

Excipient focus: DEXTRATES

sodium phenylbutyrate drug variants containing DEXTRATES

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing DEXTRATES

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: ETHYLCELLULOSES

sodium phenylbutyrate drug variants containing ETHYLCELLULOSES

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing ETHYLCELLULOSES

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

sodium phenylbutyrate drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

sodium phenylbutyrate drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
Horizon Therapeutics USA Inc	sodium phenylbutyrate	75987-060
Par Pharmaceutical Inc	sodium phenylbutyrate tablets, 500 mg	49884-170
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
Medunik USA	sodium phenylbutyrate	71770-100
>Company	>Ingredient	>NDC

Excipient focus: MALTODEXTRIN

sodium phenylbutyrate drug variants containing MALTODEXTRIN

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing MALTODEXTRIN

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES

sodium phenylbutyrate drug variants containing MEDIUM-CHAIN TRIGLYCERIDES

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing MEDIUM-CHAIN TRIGLYCERIDES

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 1500

sodium phenylbutyrate drug variants containing POLYETHYLENE GLYCOL 1500

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing POLYETHYLENE GLYCOL 1500

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K25

sodium phenylbutyrate drug variants containing POVIDONE K25

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing POVIDONE K25

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

sodium phenylbutyrate drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

sodium phenylbutyrate drug variants containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: SODIUM STEARYL FUMARATE

sodium phenylbutyrate drug variants containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SODIUM STEARYL FUMARATE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: SORBITOL

sodium phenylbutyrate drug variants containing SORBITOL

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SORBITOL

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

sodium phenylbutyrate drug variants containing STARCH, CORN

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: SUCRALOSE

sodium phenylbutyrate drug variants containing SUCRALOSE

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Company	Ingredient	NDC
Amylyx Pharmaceuticals Inc	sodium phenylbutyrate/taurursodiol	73063-035
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SUCRALOSE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

Excipient focus: SUCROSE

sodium phenylbutyrate drug variants containing SUCROSE

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Company	Ingredient	NDC
Medunik USA	sodium phenylbutyrate	71770-100
Medunik USA	sodium phenylbutyrate	71770-210
>Company	>Ingredient	>NDC

sodium phenylbutyrate drug variants not containing SUCROSE

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Company	Ingredient	NDC
Sigmapharm Laboratories LLC	sodium phenylbutyrate	42794-086
Par Pharmaceutical Inc	sodium phenylbutyrate	49884-006
GLENMARK PHARMACEUTICALS INC USA	sodium phenylbutyrate	68462-853
>Company	>Ingredient	>NDC

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