Sodium Phenylacetate and Sodium Benzoate
- Product NDC
- 70511-102
- 11-digit product format
- 705110102
- Labeler code
- 70511
- Product ID
- 70511-102_b14a3aa1-8456-404a-8afd-85d7ca272ab1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Phenylacetate and Sodium Benzoate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- MAIA PHARMACEUTICALS
- Application
- NDA215025
- Marketing category
- NDA
- Marketing start
- 2021-07-01
- 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 |
|---|
| 70511-102-20 | Sodium Phenylacetate and Sodium Benzoate | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 70511-102-20 | Sodium Phenylacetate and Sodium Benzoate | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70511-102 | SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION [MAIA PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230117_ab40b62b-9f8d-4394-92d5-09d9f1941eaa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70511-102-20 | 70511010220 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70511-102-20) / 20 mL in 1 VIAL, SINGLE-DOSE | 2021-07-01 | 0000-00-00 | No | No | Current |