NDC 71770-210

PHEBURANE

Sodium Phenylbutyrate

PHEBURANE is a Oral Pellet in the Human Prescription Drug category. It is labeled and distributed by Medunik Usa. The primary component is Sodium Phenylbutyrate.

Product ID71770-210_097c17e7-aa5d-4390-84ac-788756a24e91
NDC71770-210
Product TypeHuman Prescription Drug
Proprietary NamePHEBURANE
Generic NameSodium Phenylbutyrate
Dosage FormPellet
Route of AdministrationORAL
Marketing Start Date2022-09-14
Marketing CategoryNDA /
Application NumberNDA216513
Labeler NameMedunik USA
Substance NameSODIUM PHENYLBUTYRATE
Active Ingredient Strength483 mg/g
Pharm ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71770-210-10

174 g in 1 BOTTLE (71770-210-10)
Marketing Start Date2022-09-14
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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

Trademark Results [PHEBURANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHEBURANE
PHEBURANE
79117600 4281315 Live/Registered
LUCANE PHARMA
2012-06-05

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