NDC 67457-844

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 Mylan Institutional Llc. The primary component is Sodium Phenylacetate; Sodium Benzoate.

• Product ID: 67457-844_80c174b3-5287-4fb5-b4c1-e1d5208c249e
• NDC: 67457-844
• 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: 2017-05-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208521
• Labeler Name: Mylan Institutional LLC
• 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: 2022-12-31

Packaging

NDC 67457-844-50

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-844-50) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-844-50 [67457084450]

Sodium Phenylacetate and Sodium Benzoate INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA208521
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-23

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHENYLACETATE	100 mg/mL

OpenFDA Data

• SPL SET ID: 6802ea00-2f52-4137-8f2f-0dbf1052ebc0
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 48N6U1781G
  • OJ245FE5EU
• RxNorm Concept Unique ID - RxCUI:
  • 984118

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