Varenicline
- Product NDC
- 60687-893
- 11-digit product format
- 606870893
- Labeler code
- 60687
- Product ID
- 60687-893_459a090a-2b6b-2bff-e063-6294a90a5c7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA213019
- Marketing category
- ANDA
- Marketing start
- 2025-12-09
- 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
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-893-11 | Varenicline | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
| 60687-893-21 | Varenicline | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-893-11 | 60687089311 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-893-21 | 60687089321 | 30 BLISTER PACK in 1 CARTON (60687-893-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-893-11) | 30 blister pack | 2025-12-09 | No | No | Historical |