Varenicline
- Product NDC
- 0904-7415
- 11-digit product format
- 009047415
- Labeler code
- 0904
- Product ID
- 0904-7415_1297c291-da28-4a73-9c28-d5adee36d7b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- KIT
- Labeler
- Major Pharmaceuticals
- Application
- ANDA214557
- Marketing category
- ANDA
- Marketing start
- 2023-12-18
- 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
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636671, 636676, 749289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7415-16 | Varenicline | 1 in 1 CARTON | KIT | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7415 | VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20231223_1297c291-da28-4a73-9c28-d5adee36d7b7.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 |
|---|
| 0904-7415-16 | 00904741516 | 1 KIT in 1 CARTON (0904-7415-16) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2023-12-18 | No | No | Historical |