NDC 75987-060

BUPHENYL

Sodium Phenylbutyrate

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

Product ID75987-060_17f41eed-2800-4ec5-9bff-8d2a2a64f8ef
NDC75987-060
Product TypeHuman Prescription Drug
Proprietary NameBUPHENYL
Generic NameSodium Phenylbutyrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1996-05-13
Marketing CategoryNDA / NDA
Application NumberNDA020572
Labeler NameHorizon Therapeutics USA, Inc.
Substance NameSODIUM PHENYLBUTYRATE
Active Ingredient Strength500 mg/1
Pharm ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 75987-060-08

1 BOTTLE in 1 CARTON (75987-060-08) > 250 TABLET in 1 BOTTLE
Marketing Start Date1996-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-060-08 [75987006008]

BUPHENYL TABLET
Marketing CategoryNDA
Application NumberNDA020572
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-05-13

Drug Details

Active Ingredients

IngredientStrength
SODIUM PHENYLBUTYRATE500 mg/1

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
    72542-200OLPRUVAsodium phenylbutyrate
    72542-300OLPRUVAsodium phenylbutyrate
    72542-400OLPRUVAsodium phenylbutyrate
    72542-500OLPRUVAsodium phenylbutyrate
    72542-600OLPRUVAsodium phenylbutyrate
    72542-667OLPRUVAsodium 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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