VARENICLINE
- Product NDC
- 60290-078
- 11-digit product format
- 602900078
- Labeler code
- 60290
- Product ID
- 60290-078_48e02d69-578d-6c15-e063-6394a90ade7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Umedica Laboratories USA Inc.
- Application
- ANDA218985
- Marketing category
- ANDA
- Marketing start
- 2026-01-09
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VARENICLINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARENICLINE TARTRATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636671, 636676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60290-078-01 | VARENICLINE | 56 in 1 BOTTLE | TABLET | 56 | | 2 |
| 60290-078-02 | VARENICLINE | 60 in 1 CARTON | TABLET | 60 | | 2 |
| 60290-078-02 | VARENICLINE | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60290-078-01 | 60290007801 | 56 TABLET in 1 BOTTLE (60290-078-01) | 56 tablet | 2026-01-09 | No | No | Historical |
| 60290-078-02 | 60290007802 | 60 BLISTER PACK in 1 CARTON (60290-078-02) / 1 TABLET in 1 BLISTER PACK | 60 blister pack | 2026-01-09 | No | No | Historical |