glycerol phenylbutyrate
- Product NDC
- 70748-425
- 11-digit product format
- 707480425
- Labeler code
- 70748
- Product ID
- 70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycerol phenylbutyrate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- NDA203284
- Marketing category
- NDA
- Marketing start
- 2025-10-20
- Substance
- GLYCEROL PHENYLBUTYRATE
- Active strength
- 1.1 g/mL
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| ZH6F1VCV7B | GLYCEROL PHENYLBUTYRATE | 611168-24-2 | GLYCEROL PHENYLBUTYRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70748-425-01 | 70748042501 | 1 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE | 1 bottle | 2025-10-20 | No | No | Historical |