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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VARENICLINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARENICLINE TARTRATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-2218-2 | VARENICLINE | 56 in 1 BOTTLE | TABLET, FILM COATED | 56 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2218 | VARENICLINE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20240404_e3cc710d-23d8-4d68-b854-b6f5f4e737fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |