NDC 68382-396

SODIUM PHENYLACETATE AND SODIUM BENZOATE

Sodium Phenylacetate And Sodium Benzoate

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

Packaging

NDC 68382-396-01

1 VIAL in 1 CARTON (68382-396-01) > 50 mL in 1 VIAL

• Marketing Start Date: 2021-02-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68382-396-01 [68382039601]

SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA205880
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-01

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHENYLACETATE	100 mg/mL

OpenFDA Data

• SPL SET ID: 204e84a7-5440-4537-9e40-06eb56c415e9
• Manufacturer:
  • Zydus Pharmaceuticals USA Inc.
• UNII:
  • 48N6U1781G
  • OJ245FE5EU
• RxNorm Concept Unique ID - RxCUI:
  • 984118
• UPC Code:
  • 0368382396013

Pharmacological Class

• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]

NDC Crossover Matching brand name "SODIUM PHENYLACETATE AND SODIUM BENZOATE" or generic name "Sodium Phenylacetate And Sodium Benzoate"

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