Sodium Phenylacetate and Sodium Benzoate is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Oceanside Pharmaceuticals. The primary component is Sodium Phenylacetate; Sodium Benzoate.
| Product ID | 68682-001_1f714ab4-b9f2-4779-b2ea-39ef9d1c3db5 |
| NDC | 68682-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Sodium Phenylacetate and Sodium Benzoate |
| Generic Name | Sodium Phenylacetate And Sodium Benzoate |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-03-15 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA020645 |
| Labeler Name | Oceanside Pharmaceuticals |
| Substance Name | SODIUM PHENYLACETATE; SODIUM BENZOATE |
| Active Ingredient Strength | 100 mg/mL; mg/mL |
| Pharm Classes | Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-03-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA authorized generic |
| Application Number | NDA020645 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-03-15 |
| Ingredient | Strength |
|---|---|
| SODIUM PHENYLACETATE | 100 mg/mL |
| SPL SET ID: | 584c5642-9a84-4577-b766-bcb182730b1e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13811-705 | SODIUM PHENYLACETATE and SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 67457-844 | Sodium Phenylacetate and Sodium Benzoate | Sodium Phenylacetate and Sodium Benzoate |
| 68382-396 | SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 68475-001 | Sodium Phenylacetate and sodium benzoate | Sodium Phenylacetate and sodium benzoate |
| 68682-001 | Sodium Phenylacetate and Sodium Benzoate | sodium phenylacetate and sodium benzoate |
| 69784-810 | SODIUM PHENYLACETATE and SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 69784-811 | SODIUM PHENYLACETATE and SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 70511-101 | SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 70511-102 | Sodium Phenylacetate and Sodium Benzoate | Sodium Phenylacetate and Sodium Benzoate |
| 70556-100 | SODIUM PHENYLACETATE and SODIUM BENZOATE | sodium phenylacetate and sodium benzoate |
| 72266-236 | Sodium Phenylacetate and Sodium Benzoate | Sodium Phenylacetate and Sodium Benzoate |
| 72266-247 | Sodium Phenylacetate and Sodium Benzoate | Sodium Phenylacetate and Sodium Benzoate |
| 0187-0010 | Ammonul | sodium phenylacetate and sodium benzoate |
| 62592-720 | Ammonul | sodium phenylacetate and sodium benzoate |