NDC 0187-0010

Ammonul

Sodium Phenylacetate And Sodium Benzoate

Ammonul is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Sodium Phenylacetate; Sodium Benzoate.

• Product ID: 0187-0010_52b3bdce-3055-457f-bc85-75767009bdc8
• NDC: 0187-0010
• Product Type: Human Prescription Drug
• Proprietary Name: Ammonul
• Generic Name: Sodium Phenylacetate And Sodium Benzoate
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2005-02-17
• Marketing Category: NDA / NDA
• Application Number: NDA020645
• Labeler Name: Bausch Health US 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: 2021-12-31

Packaging

NDC 0187-0010-50

1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) > 50 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2005-02-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0010-50 [00187001050]

Ammonul INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA020645
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-02-17

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHENYLACETATE	100 mg/mL

OpenFDA Data

• SPL SET ID: e00521d3-84f1-4586-b4a8-9dc17ffffcb1
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 48N6U1781G
  • OJ245FE5EU
• RxNorm Concept Unique ID - RxCUI:
  • 984120
  • 984118

Pharmacological Class

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

NDC Crossover Matching brand name "Ammonul" or generic name "Sodium Phenylacetate And Sodium Benzoate"

NDC	Brand Name	Generic Name
0187-0010	Ammonul	sodium phenylacetate and sodium benzoate
62592-720	Ammonul	sodium phenylacetate and sodium benzoate
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