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NDC 68382-0396-01 SODIUM PHENYLACETATE AND SODIUM BENZOATE 100; 100 mg/mL; mg/mL Details
SODIUM PHENYLACETATE AND SODIUM BENZOATE 100; 100 mg/mL; mg/mL
SODIUM PHENYLACETATE AND SODIUM BENZOATE is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is SODIUM BENZOATE; SODIUM PHENYLACETATE.
Product Information
| NDC | 68382-0396 |
|---|---|
| Product ID | 68382-396_41052ba8-e11b-444d-8e3a-e2045768f7e3 |
| Associated GPIs | 30908050102060 |
| GCN Sequence Number | 058808 |
| GCN Sequence Number Description | sodium benzoate/sod phenylacet VIAL 10 %-10 % INTRAVEN |
| HIC3 | D9A |
| HIC3 Description | AMMONIA INHIBITORS |
| GCN | 24322 |
| HICL Sequence Number | 001398 |
| HICL Sequence Number Description | SODIUM BENZOATE/SODIUM PHENYLACETATE |
| Brand/Generic | Generic |
| Proprietary Name | SODIUM PHENYLACETATE AND SODIUM BENZOATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium phenylacetate and sodium benzoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100; 100 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | SODIUM BENZOATE; SODIUM PHENYLACETATE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205880 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0396-01 (68382039601)
| NDC Package Code | 68382-396-01 |
|---|---|
| Billing NDC | 68382039601 |
| Package | 1 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL |
| Marketing Start Date | 2021-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |