NDC 75987-070

Buphenyl

Sodium Phenylbutyrate

Buphenyl is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Sodium Phenylbutyrate.

Product ID75987-070_17f41eed-2800-4ec5-9bff-8d2a2a64f8ef
NDC75987-070
Product TypeHuman Prescription Drug
Proprietary NameBuphenyl
Generic NameSodium Phenylbutyrate
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date1996-04-30
Marketing CategoryNDA / NDA
Application NumberNDA020573
Labeler NameHorizon Therapeutics USA, Inc.
Substance NameSODIUM PHENYLBUTYRATE
Active Ingredient Strength1 g/g
Pharm ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 75987-070-09

1 BOTTLE in 1 CARTON (75987-070-09) > 250 g in 1 BOTTLE
Marketing Start Date1996-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-070-09 [75987007009]

Buphenyl POWDER
Marketing CategoryNDA
Application NumberNDA020573
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-04-30

Drug Details

Active Ingredients

IngredientStrength
SODIUM PHENYLBUTYRATE.94 g/g

OpenFDA Data

SPL SET ID:463a36fa-3eb2-4326-8bd0-c8c7a11bca3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213196
  • 199369
  • 984105
  • 984107
  • Pharmacological Class

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

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

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

    Trademark Results [Buphenyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BUPHENYL
    BUPHENYL
    75361053 2203912 Live/Registered
    HORIZON THERAPEUTICS, LLC
    1997-09-22

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