NDC 59148-053

Nuedexta

Dextromethorphan Hydrobromide And Quinidine Sulfate

Nuedexta is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc. The primary component is Dextromethorphan Hydrobromide; Quinidine Sulfate.

• Product ID: 59148-053_45a295af-13b7-4a84-a5dc-0e8ed051f323
• NDC: 59148-053
• Product Type: Human Prescription Drug
• Proprietary Name: Nuedexta
• Generic Name: Dextromethorphan Hydrobromide And Quinidine Sulfate
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2023-01-03
• Marketing Category: NDA /
• Application Number: NDA021879
• Labeler Name: Otsuka America Pharmaceutical, Inc
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
• Active Ingredient Strength: 20 mg/1; mg/1
• Pharm Classes: Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 59148-053-16

60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)

• Marketing Start Date: 2023-01-03
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Nuedexta" or generic name "Dextromethorphan Hydrobromide And Quinidine Sulfate"

NDC	Brand Name	Generic Name
59148-053	Nuedexta	dextromethorphan hydrobromide and quinidine sulfate
64597-301	NUEDEXTA	dextromethorphan hydrobromide and quinidine sulfate