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 Phenylacetate; Sodium Benzoate.
Product ID | 68382-396_16967735-f256-4d2d-8161-bc86bfa54304 |
NDC | 68382-396 |
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 | 2020-12-22 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA205880 |
Labeler Name | Zydus Pharmaceuticals USA Inc. |
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 | 2021-02-08 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA205880 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2016-09-01 |
Ingredient | Strength |
---|---|
SODIUM PHENYLACETATE | 100 mg/mL |
SPL SET ID: | 204e84a7-5440-4537-9e40-06eb56c415e9 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
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 |