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NDC 64597-0301-13 NUEDEXTA 20; 10 mg/1; mg/1 Details
NUEDEXTA 20; 10 mg/1; mg/1
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.
MedlinePlus Drug Summary
The combination of dextromethorphan and quinidine is used to treat pseudobulbar affect (PBA; a condition of sudden, frequent outbursts of crying or laughing that can not be controlled) in people with certain conditions such as amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken) or multiple sclerosis (a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control). Dextromethorphan is in a class of medications called central nervous system agents. The way it works in the brain to treat PBA is not known. Quinidine is in a class of medications called antiarrhythmics. When combined with dextromethorphan, quinidine works by increasing the amount of dextromethorphan in the body.
Related Packages: 64597-0301-13Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan and Quinidine
Product Information
| NDC | 64597-0301 |
|---|---|
| Product ID | 64597-301_0f916cea-0d2b-4d75-8b68-25be67cbcd99 |
| Associated GPIs | 62609902300120 |
| GCN Sequence Number | 066871 |
| GCN Sequence Number Description | dextromethorphan Hbr/quinidine CAPSULE 20 MG-10MG ORAL |
| HIC3 | H8O |
| HIC3 Description | PSEUDOBULBAR AFFECT (PBA) AGENTS, NMDA ANTAGONISTS |
| GCN | 29290 |
| HICL Sequence Number | 037278 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/QUINIDINE SULFATE |
| Brand/Generic | Brand |
| Proprietary Name | NUEDEXTA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan hydrobromide and quinidine sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 20; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
| Labeler Name | Avanir Pharmaceuticals, Inc. |
| Pharmaceutical Class | 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 |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021879 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64597-0301-13 (64597030113)
| NDC Package Code | 64597-301-13 |
|---|---|
| Billing NDC | 64597030113 |
| Package | 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 |
| Pricing Information | N/A |