AUVELITY
- Product NDC
- 81968-030
- 11-digit product format
- 819680030
- Labeler code
- 81968
- Product ID
- 81968-030_73a644ad-38d5-49a7-9e96-187d20dffbd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, bupropion hydrochloride
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Axsome Therapeutics, Inc.
- Application
- NDA215430
- Marketing category
- NDA
- Marketing start
- 2026-05-08
- Substance
- BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 105; 30 mg/1; mg/1
- Pharmacologic classes
- 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-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AUVELITY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPROPION HYDROCHLORIDE | 105 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, ZG7E5POY8O |
| Rxcui | 2611260, 2611266, 2741701, 2741703, 2744512, 2744513, 2744514, 2744515 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81968-030-22 | AUVELITY | 21 in 1 BOTTLE | TABLET, MULTILAYER, EXTENDED REL | 21 | | 14 |
| 81968-030-22 | AUVELITY | 1 in 1 CARTON | TABLET, MULTILAYER, EXTENDED REL | 1 | | 14 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81968-030-22 | 81968003022 | 1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2026-05-08 | Yes | No | Current |