NDC 49884-006

Sodium Phenylbutyrate

Sodium Phenylbutyrate

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

Product ID49884-006_4584c707-7c10-4c8d-8ed9-693cc576ac97
NDC49884-006
Product TypeHuman Prescription Drug
Proprietary NameSodium Phenylbutyrate
Generic NameSodium Phenylbutyrate
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date2016-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA203918
Labeler NamePar Pharmaceutical, Inc.
Substance NameSODIUM PHENYLBUTYRATE
Active Ingredient Strength1 g/g
Pharm ClassesAmmonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49884-006-04

1 BOTTLE in 1 CARTON (49884-006-04) > 250 g in 1 BOTTLE
Marketing Start Date2016-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-006-04 [49884000604]

Sodium Phenylbutyrate POWDER
Marketing CategoryANDA
Application NumberANDA203918
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-08-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM PHENYLBUTYRATE.94 g/g

OpenFDA Data

SPL SET ID:639f5c7e-9f6d-47fb-a417-2be076176a78
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 984105
  • UPC Code
  • 0349884006044
  • Pharmacological Class

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

    Medicade Reported Pricing

    49884006601 GLYCOPYRROLATE 2 MG TABLET

    Pricing Unit: EA | Drug Type:

    49884006501 GLYCOPYRROLATE 1 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    42794-086Sodium PhenylbutyrateSodium Phenylbutyrate
    49884-006Sodium PhenylbutyrateSodium Phenylbutyrate
    49884-170Sodium PhenylbutyrateSodium Phenylbutyrate Tablets, 500 mg
    68462-853sodium phenylbutyratesodium phenylbutyrate
    75987-060BUPHENYLsodium phenylbutyrate
    75987-070Buphenylsodium phenylbutyrate
    71770-100PHEBURANESodium phenylbutyrate
    71770-200PHEBURANESodium phenylbutyrate
    71770-210PHEBURANESodium phenylbutyrate

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.