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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- glycerol phenylbutyrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCEROL PHENYLBUTYRATE | 1.1 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZH6F1VCV7B |
| Rxcui | 1368453 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70748-425-01 | glycerol phenylbutyrate | 25 mL in 1 BOTTLE | LIQUID | 25 | | 1 |
| 70748-425-01 | glycerol phenylbutyrate | 1 in 1 CARTON | LIQUID | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |