Varenicline
- Product NDC
- 27241-174
- 11-digit product format
- 272410174
- Labeler code
- 27241
- Product ID
- 27241-174_1c32f27d-6637-481f-9df9-9ef064fd86e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA213019
- Marketing category
- ANDA
- Marketing start
- 2024-01-31
- 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 | 636671, 636676, 749289, 749788 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27241-174-11 | Varenicline | 56 in 1 BLISTER PACK | TABLET, FILM COATED | 56 | | 6 |
| 27241-174-56 | Varenicline | 56 in 1 BOTTLE | TABLET, FILM COATED | 56 | | 6 |
| 27241-174-77 | Varenicline | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-174 | VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [AJANTA PHARMA USA INC.] | 5 | Current NDC, 3 package rows | 20240322_2f86bb7b-c6a6-4915-8ba1-17251540971c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 27241-174-11 | 27241017411 | 56 in 1 BLISTER PACK | | | | | Historical |
| 27241-174-56 | 27241017456 | 56 TABLET, FILM COATED in 1 BOTTLE (27241-174-56) | | 2024-01-31 | No | No | Historical |
| 27241-174-77 | 27241017477 | 4 BLISTER PACK in 1 CARTON (27241-174-77) / 56 TABLET, FILM COATED in 1 BLISTER PACK (27241-174-11) | 4 blister pack | 2024-01-31 | No | No | Historical |