NDC 49884-170

Sodium Phenylbutyrate

Sodium Phenylbutyrate Tablets, 500 Mg

Sodium Phenylbutyrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Sodium Phenylbutyrate.

• Product ID: 49884-170_682dc4ca-6e05-435d-bc94-708d19acdea8
• NDC: 49884-170
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Phenylbutyrate
• Generic Name: Sodium Phenylbutyrate Tablets, 500 Mg
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-04-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204395
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: SODIUM PHENYLBUTYRATE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49884-170-04

1 BOTTLE in 1 CARTON (49884-170-04) > 250 TABLET in 1 BOTTLE

• Marketing Start Date: 2016-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49884-170-04 [49884017004]

Sodium Phenylbutyrate TABLET

• Marketing Category: ANDA
• Application Number: ANDA204395
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-29

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHENYLBUTYRATE	500 mg/1

OpenFDA Data

• SPL SET ID: 4020b962-eaee-4184-b04b-14ca757c51a1
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • NT6K61736T
• RxNorm Concept Unique ID - RxCUI:
  • 199369
• UPC Code:
  • 0349884170042

Pharmacological Class

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

NDC Crossover Matching brand name "Sodium Phenylbutyrate" or generic name "Sodium Phenylbutyrate Tablets, 500 Mg"

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