VARENICLINE TARTRATE
- Product NDC
- 70748-125
- 11-digit product format
- 707480125
- Labeler code
- 70748
- Product ID
- 70748-125_3647a217-0da1-4778-adea-08d19a9c446f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE TARTRATE
- Dosage form
- KIT
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA211862
- Marketing category
- ANDA
- Marketing start
- 2024-03-20
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VARENICLINE TARTRATE
- 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 |
|---|
| 70748-125-13 | VARENICLINE TARTRATE | 1 in 1 CARTON | KIT | 1 | | 14 |
| 70748-125-13 | VARENICLINE TARTRATE | 1 in 1 BLISTER PACK | KIT | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-125 | VARENICLINE TABLET, FILM COATED VARENICLINE TARTRATE (VARENICLINE TARTRATE ) KIT [LUPIN PHARMACEUTICALS, INC.] | 8 | Current NDC, 2 package rows | 20240405_bf20c4cc-1731-4873-8de1-b93d17591e9f.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 |
|---|
| 70748-125-13 | 70748012513 | 1 BLISTER PACK in 1 CARTON (70748-125-13) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2024-03-20 | No | No | Current |