NDC 68462-853

sodium phenylbutyrate

Sodium Phenylbutyrate

sodium phenylbutyrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Sodium Phenylbutyrate.

Product ID68462-853_0c76d25b-abac-41a3-a547-4fa4796bf7a4
NDC68462-853
Product TypeHuman Prescription Drug
Proprietary Namesodium phenylbutyrate
Generic NameSodium Phenylbutyrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-11-01
Marketing CategoryANDA /
Application NumberANDA216462
Labeler NameGLENMARK PHARMACEUTICALS INC., USA
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 68462-853-20

250 TABLET in 1 BOTTLE (68462-853-20)
Marketing Start Date2022-11-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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
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

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