Varenicline
- Product NDC
- 49884-944
- 11-digit product format
- 498840944
- Labeler code
- 49884
- Product ID
- 49884-944_f703e1ca-8acc-4b42-ac8a-4a90b749cbe7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline tartrate
- Dosage form
- KIT
- Labeler
- Par Health USA, LLC
- Application
- ANDA201785
- Marketing category
- ANDA
- Marketing start
- 2021-09-21
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Varenicline
- Listing expiration
- 2027-12-31
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 |
|---|
| 49884-944-99 | Varenicline | 1 in 1 BOX | KIT | 1 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-944 | VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [ENDO USA, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20240523_9e5c0ef3-3179-4d7b-bc76-901473c73ce8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-944-99 | 49884094499 | 1 KIT in 1 BOX (49884-944-99) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2021-09-21 | 0000-00-00 | No | No | Current |