VARENICLINE TARTRATE
- Product NDC
- 69315-404
- 11-digit product format
- 693150404
- Labeler code
- 69315
- Product ID
- 69315-404_cd15d74e-92d3-4bf0-8c76-a01f9190b172
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE TARTRATE
- Dosage form
- KIT
- Labeler
- Leading Pharma, LLC
- Application
- ANDA217151
- Marketing category
- ANDA
- Marketing start
- 2023-10-01
- 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, 749788 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-404-57 | VARENICLINE TARTRATE | 1 in 1 BOX | KIT | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-404 | VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE KIT [LEADING PHARMA, LLC] | 7 | Current NDC, 1 package rows | 20241129_fdb36cfa-d20a-4fd9-b994-a5d16e4bb438.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 |
|---|
| 69315-404-57 | 69315040457 | 1 KIT in 1 BOX (69315-404-57) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2023-10-01 | No | No | Current |