Glycerol Phenylbutyrate
- Product NDC
- 49884-264
- 11-digit product format
- 498840264
- Labeler code
- 49884
- Product ID
- 49884-264_88787621-3d7b-4665-9535-9e14d67aba66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycerol Phenylbutyrate oral
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA205742
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- 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 |
|---|
| 49884-264-95 | Glycerol Phenylbutyrate | 25 mL in 1 BOTTLE | LIQUID | 25 | | 23 |
| 49884-264-95 | Glycerol Phenylbutyrate | 1 in 1 CARTON | LIQUID | 1 | | 23 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49884-264-95 | 49884026495 | 1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE | 1 bottle | 2025-10-17 | No | No | Current |