SODIUM PHENYLACETATE and SODIUM BENZOATE
- Product NDC
- 81665-204
- 11-digit product format
- 816650204
- Labeler code
- 81665
- Product ID
- 81665-204_03dcc78e-b47c-46dc-b7be-b6e6dcb0d071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium phenylacetate and sodium benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Omnivium Pharmaceuticals LLC
- Application
- ANDA207096
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- Substance
- SODIUM BENZOATE; SODIUM PHENYLACETATE
- Active strength
- 100; 100 mg/mL; mg/mL
- Pharmacologic classes
- Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], 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
- SODIUM PHENYLACETATE and SODIUM BENZOATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM BENZOATE | 100 mg/mL |
| SODIUM PHENYLACETATE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OJ245FE5EU, 48N6U1781G |
| Rxcui | 984118 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81665-204-01 | SODIUM PHENYLACETATE and SODIUM BENZOATE | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 1 |
| 81665-204-01 | SODIUM PHENYLACETATE and SODIUM BENZOATE | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 50 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81665-204-01 | 81665020401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE | 2025-05-15 | No | No | Historical |