varenicline
- Product NDC
- 50090-7135
- 11-digit product format
- 500907135
- Labeler code
- 50090
- Product ID
- 50090-7135_cc56f26e-8b25-442c-a8b1-c3dfc7fee841
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA214557
- Marketing category
- ANDA
- Marketing start
- 2023-08-25
- Substance
- VARENICLINE TARTRATE
- Active strength
- .5 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 82269ASB48 | VARENICLINE TARTRATE | 375815-87-5 | VARENICLINE TARTRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7135-0 | 50090713500 | 56 TABLET, FILM COATED in 1 BOTTLE (50090-7135-0) | 2024-04-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| varenicline | A-S Medication Solutions | 2024-04-29 | Human Prescription Drug Label | 2 |