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 |
Marketing Start Date | 2022-08-26 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208843 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2018-02-06 |
Ingredient | Strength |
---|---|
HYDROXYUREA | 100 mg/1 |
SPL SET ID: | 76957c0d-0f98-4376-bb06-eee651adc09d |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PHEBURANE 79117600 4281315 Live/Registered |
LUCANE PHARMA 2012-06-05 |