Varenicline
- Product NDC
- 59651-451
- 11-digit product format
- 596510451
- Labeler code
- 59651
- Product ID
- 59651-451_0004a0bb-87c0-46f8-b36a-95c98107395d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline
- Dosage form
- KIT
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214595
- Marketing category
- ANDA
- Marketing start
- 2025-05-02
- 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 |
|---|
| 59651-451-53 | 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 |
|---|
| 59651-451 | VARENICLINE TABLET, FILM COATED VARENICLINE KIT [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 1 package rows | 20250510_0004a0bb-87c0-46f8-b36a-95c98107395d.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 |
|---|
| 59651-451-53 | 59651045153 | 1 KIT in 1 CARTON (59651-451-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2025-05-02 | No | No | Current |