NDC 42794-086

Sodium Phenylbutyrate

Sodium Phenylbutyrate

Sodium Phenylbutyrate is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Sodium Phenylbutyrate.

• Product ID: 42794-086_72cbabc5-73af-0e64-e053-2a91aa0a16f1
• NDC: 42794-086
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Phenylbutyrate
• Generic Name: Sodium Phenylbutyrate
• Dosage Form: Powder
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202819
• Labeler Name: Sigmapharm Laboratories, LLC
• Substance Name: SODIUM PHENYLBUTYRATE
• Active Ingredient Strength: 1 g/g
• Pharm Classes: Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42794-086-14

1 BOTTLE in 1 CARTON (42794-086-14) > 250 g in 1 BOTTLE

• Marketing Start Date: 2011-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42794-086-14 [42794008614]

Sodium Phenylbutyrate POWDER

• Marketing Category: ANDA
• Application Number: ANDA202819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-11-30

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHENYLBUTYRATE	.94 g/g

OpenFDA Data

• SPL SET ID: e914d451-6122-43f9-af8d-c80ed1cb215d
• Manufacturer:
  • Sigmapharm Laboratories, LLC
• UNII:
  • NT6K61736T
• RxNorm Concept Unique ID - RxCUI:
  • 984105
• UPC Code:
  • 0342794086144

Pharmacological Class

• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]

NDC Crossover Matching brand name "Sodium Phenylbutyrate" or generic name "Sodium Phenylbutyrate"

NDC	Brand Name	Generic Name
42794-086	Sodium Phenylbutyrate	Sodium Phenylbutyrate
49884-006	Sodium Phenylbutyrate	Sodium Phenylbutyrate
49884-170	Sodium Phenylbutyrate	Sodium Phenylbutyrate Tablets, 500 mg
68462-853	sodium phenylbutyrate	sodium phenylbutyrate
75987-060	BUPHENYL	sodium phenylbutyrate
75987-070	Buphenyl	sodium phenylbutyrate
72542-200	OLPRUVA	sodium phenylbutyrate
72542-300	OLPRUVA	sodium phenylbutyrate
72542-400	OLPRUVA	sodium phenylbutyrate
72542-500	OLPRUVA	sodium phenylbutyrate
72542-600	OLPRUVA	sodium phenylbutyrate
72542-667	OLPRUVA	sodium phenylbutyrate
71770-100	PHEBURANE	Sodium phenylbutyrate
71770-200	PHEBURANE	Sodium phenylbutyrate
71770-210	PHEBURANE	Sodium phenylbutyrate