NDC 64597-301

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 Avanir Pharmaceuticals, Inc.. The primary component is Dextromethorphan Hydrobromide; Quinidine Sulfate.

• Product ID: 64597-301_2668675a-5794-465a-9914-a02b37f78f16
• NDC: 64597-301
• 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: 2010-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA021879
• Labeler Name: Avanir Pharmaceuticals, 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: 2023-12-31

Packaging

NDC 64597-301-13

1 BOTTLE in 1 CARTON (64597-301-13) > 13 CAPSULE, GELATIN COATED in 1 BOTTLE

• Marketing Start Date: 2010-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64597-301-13 [64597030113]

NUEDEXTA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA021879
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-01

NDC 64597-301-60 [64597030160]

NUEDEXTA CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA021879
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-12-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1

OpenFDA Data

• SPL SET ID: 484e0918-3442-49dc-8ccf-177f1f3ee9f3
• Manufacturer:
  • Avanir Pharmaceuticals, Inc.
• UNII:
  • J13S2394HE
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1040058
  • 1040054

Pharmacological Class

• Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
• Sigma-1 Agonist [EPC]
• Uncompetitive NMDA Receptor Antagonists [MoA]
• Sigma-1 Receptor Agonists [MoA]
• Antiarrhythmic [EPC]
• Cytochrome P450 2D6 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]

Medicade Reported Pricing

64597030160 NUEDEXTA 20-10 MG CAPSULE

Pricing Unit: EA | Drug Type:

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