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NDC 81968-0045-30 AUVELITY 105; 45 mg/1; mg/1 Details
AUVELITY 105; 45 mg/1; mg/1
AUVELITY is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Axsome Therapeutics, Inc.. The primary component is BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE.
MedlinePlus Drug Summary
Bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL) is used to treat depression. Bupropion (Aplenzin, Wellbutrin XL) is also used to treat seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion (Zyban) is used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.
Related Packages: 81968-0045-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bupropion
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 81968-0045-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 81968-0045 |
|---|---|
| Product ID | 81968-045_ed41b2a2-19c2-4357-8818-712d09c8ba79 |
| Associated GPIs | |
| GCN Sequence Number | 083732 |
| GCN Sequence Number Description | dextromethorphan HBr/bupropion TAB IR ER 45MG-105MG ORAL |
| HIC3 | H81 |
| HIC3 Description | NDMA RECEPTOR ANTAGONIST AND NDRI COMB |
| GCN | 52775 |
| HICL Sequence Number | 048220 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/BUPROPION HCL |
| Brand/Generic | Brand |
| Proprietary Name | AUVELITY |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan hydrobromide, bupropion hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 105; 45 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
| Labeler Name | Axsome Therapeutics, Inc. |
| Pharmaceutical Class | Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-asparta |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215430 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 81968-0045-30 (81968004530)
| NDC Package Code | 81968-045-30 |
|---|---|
| Billing NDC | 81968004530 |
| Package | 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) |
| Marketing Start Date | 2022-08-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 17.7174 |
| Pricing Unit | EA |
| Effective Date | 2023-10-23 |
| NDC Description | AUVELITY ER 45-105 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 2 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |