VARENICLINE
- Product NDC
- 51407-755
- 11-digit product format
- 514070755
- Labeler code
- 51407
- Product ID
- 51407-755_369c76b6-f233-04fc-e063-6294a90a7443
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA201962
- Marketing category
- ANDA
- Marketing start
- 2023-01-25
- 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 |
| W6HS99O8ZO | VARENICLINE | 249296-44-4 | VARENICLINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51407-755-56 | 51407075556 | 56 TABLET, FILM COATED in 1 BOTTLE (51407-755-56) | 2023-04-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| VARENICLINE | Golden State Medical Supply, Inc. | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 3 |