Varenicline
- Product NDC
- 0378-5090
- 11-digit product format
- 003785090
- Labeler code
- 0378
- Product ID
- 0378-5090_5b7b6e3b-f427-4000-b252-968f3adbaa3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202019
- Marketing category
- ANDA
- Marketing start
- 2024-03-14
- Marketing end
- 2026-07-31
- Substance
- VARENICLINE TARTRATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 82269ASB48 | VARENICLINE TARTRATE | 375815-87-5 | VARENICLINE TARTRATE |
| W6HS99O8ZO | VARENICLINE | 249296-44-4 | Varenicline |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5090-73 | 00378509073 | 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5090-73) | 2024-03-14 | 2026-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Varenicline | Mylan Pharmaceuticals Inc. | 2023-04-15 | HUMAN PRESCRIPTION DRUG LABEL | 3 |