Sodium Phenylbutyrate

FDA Approved: * November 18, 2011
Pharm Company: * AMPOLGEN
Category: Hyperammonemia

Sodium phenylbutyrate is a salt of an aromatic fatty acid, 4-phenylbutyrate (4-PBA) or 4-phenylbutyric acid.[2] The compound is used to treat urea cycle disorders, because its metabolites offer an alternative pathway to the urea cycle to allow excretion of excess nitrogen.[3][4] It is an orphan drug, marketed by Ucyclyd Pharma under the trade name Buphenyl, by Swedish Orphan International (Sweden) as Ammonaps, aby Fyrlklövern Scandinavia as... [wikipedia]

* May have multiple approval dates, manufacturers, or labelers.

Dosage List

Sodium Phenylbutyrate .94 g/g Oral Powder
NDC: 42794-086
Labeler:
Sigmapharm Laboratories, LLC
Sodium Phenylbutyrate 500 mg Oral Tablet
NDC: 46672-851
Labeler:
Mikart, Inc.
Sodium Phenylbutyrate .94 g/g Oral Powder
NDC: 49884-006
Labeler:
Par Pharmaceutical, Inc.
Sodium Phenylbutyrate 500 mg Oral Tablet
NDC: 49884-170
Labeler:
Par Pharmaceutical, Inc.
Sodium Phenylbutyrate 500 mg Oral Tablet
NDC: 68462-853
Labeler:
Glenmark Pharmaceuticals Inc., USA

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