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 |
Marketing Start Date | 2010-12-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021879 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-12-01 |
Marketing Category | NDA |
Application Number | NDA021879 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2010-12-01 |
Ingredient | Strength |
---|---|
DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
SPL SET ID: | 484e0918-3442-49dc-8ccf-177f1f3ee9f3 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
59148-053 | Nuedexta | dextromethorphan hydrobromide and quinidine sulfate |
64597-301 | NUEDEXTA | dextromethorphan hydrobromide and quinidine sulfate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NUEDEXTA 85220477 not registered Dead/Abandoned |
AVANIR PHARMACEUTICALS, INC. 2011-01-18 |
![]() NUEDEXTA 78973714 3946056 Live/Registered |
Avanir Pharmaceuticals, Inc. 2006-09-13 |