Varenicline
- Product NDC
- 70518-4647
- 11-digit product format
- 705184647
- Labeler code
- 70518
- Product ID
- 70518-4647_509a27cf-3a10-af7a-e063-6394a90abf32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214571
- Marketing category
- ANDA
- Marketing start
- 2026-04-29
- 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
- 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 | .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 |
|---|
| 70518-4647-0 | Varenicline | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 2 |
| 70518-4647-1 | Varenicline | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 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 |
|---|
| 70518-4647-0 | 70518464700 | 50 BLISTER PACK in 1 BOX (70518-4647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK (70518-4647-1) | 50 blister pack | 2026-04-29 | No | No | Historical |
| 70518-4647-1 | 70518464701 | 1 in 1 BLISTER PACK | | | | | Historical |