VARENICLINE
- Product NDC
- 72162-2218
- 11-digit product format
- 721622218
- Labeler code
- 72162
- Product ID
- 72162-2218_e3cc710d-23d8-4d68-b854-b6f5f4e737fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA201962
- Marketing category
- ANDA
- Marketing start
- 2023-01-30
- 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 |
|---|
| 72162-2218-2 | 72162221802 | 56 TABLET, FILM COATED in 1 BOTTLE (72162-2218-2) | 2023-01-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| VARENICLINE | Bryant Ranch Prepack | 2024-04-02 | HUMAN PRESCRIPTION DRUG LABEL | 101 |