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 | 71770-210_097c17e7-aa5d-4390-84ac-788756a24e91 | 
| NDC | 71770-210 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | PHEBURANE | 
| Generic Name | Sodium Phenylbutyrate | 
| Dosage Form | Pellet | 
| Route of Administration | ORAL | 
| Marketing Start Date | 2022-09-14 | 
| Marketing Category | 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 | 2022-09-14 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| 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  |