Sodium phenylacetate and Sodium benzoate
- Product NDC
- 68475-513
- 11-digit product format
- 684750513
- Labeler code
- 68475
- Product ID
- 68475-513_1c41d0b4-cb49-468a-a9f3-6eeb22dd836f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium phenylacetate and Sodium benzoate
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Navinta LLC
- Application
- ANDA217526
- Marketing category
- ANDA
- Marketing start
- 2025-12-06
- 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 | 2560228 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68475-513-01 | Sodium phenylacetate and Sodium benzoate | 20 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 20 | | 1 |
| 68475-513-01 | Sodium phenylacetate and Sodium benzoate | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 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 |
|---|
| 68475-513-01 | 68475051301 | 1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL | 1 vial | 2025-12-06 | No | No | Historical |