Sodium phenylbutyrate
- Product NDC
- 70710-2180
- 11-digit product format
- 707102180
- Labeler code
- 70710
- Product ID
- 70710-2180_47ef97e0-8853-4254-b969-1a489764cec1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium phenylbutyrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA220418
- Marketing category
- ANDA
- Marketing start
- 2026-03-23
- Substance
- SODIUM PHENYLBUTYRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium phenylbutyrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM PHENYLBUTYRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NT6K61736T |
| Rxcui | 199369 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-2180-8 | Sodium phenylbutyrate | 250 in 1 BOTTLE | TABLET | 250 | | 2 |
| 70710-2180-8 | Sodium phenylbutyrate | 1 in 1 CARTON | TABLET | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-2180-8 | 70710218008 | 1 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE | 1 bottle | 2026-03-23 | No | No | Current |