NDC 71770-100

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 ID: 71770-100_5c309e18-6001-4bd1-93ae-17be10c3dad4
• NDC: 71770-100
• Product Type: Human Prescription Drug
• Proprietary Name: PHEBURANE
• Generic Name: Sodium Phenylbutyrate
• Dosage Form: Pellet
• Route of Administration: ORAL
• Marketing Start Date: 2022-08-26
• Marketing Category: NDA / NDA
• Application Number: NDA216513
• Labeler Name: Medunik USA
• Substance Name: SODIUM PHENYLBUTYRATE
• Active Ingredient Strength: 483 mg/g
• Pharm Classes: Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71770-100-10

174 g in 1 BOTTLE (71770-100-10)

• Marketing Start Date: 2022-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71770-100-60 [71770010060]

Siklos TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208843
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-06

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXYUREA	100 mg/1

OpenFDA Data

• SPL SET ID: 76957c0d-0f98-4376-bb06-eee651adc09d
• Manufacturer:
  • Medunik
• UNII:
  • X6Q56QN5QC
• RxNorm Concept Unique ID - RxCUI:
  • 1999308
  • 1999316
  • 283475
  • 1999314

Pharmacological Class

• Antimetabolite [EPC]
• Urea [CS]
• Antimetabolite [EPC]
• Urea [CS]

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

NDC	Brand Name	Generic Name
71770-100	PHEBURANE	Sodium phenylbutyrate
71770-200	PHEBURANE	Sodium phenylbutyrate
71770-210	PHEBURANE	Sodium phenylbutyrate
75987-060	BUPHENYL	sodium phenylbutyrate
75987-070	Buphenyl	sodium phenylbutyrate
72542-200	OLPRUVA	sodium phenylbutyrate
72542-300	OLPRUVA	sodium phenylbutyrate
72542-400	OLPRUVA	sodium phenylbutyrate
72542-500	OLPRUVA	sodium phenylbutyrate
72542-600	OLPRUVA	sodium phenylbutyrate
72542-667	OLPRUVA	sodium phenylbutyrate
42794-086	Sodium Phenylbutyrate	Sodium Phenylbutyrate
49884-006	Sodium Phenylbutyrate	Sodium Phenylbutyrate
68462-853	sodium phenylbutyrate	sodium phenylbutyrate