CHANTIX
- Product NDC
- 43353-899
- 11-digit product format
- 433530899
- Labeler code
- 43353
- Product ID
- 43353-899_45cfd34d-08ac-40a8-95b3-21d3fea687c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021928
- Marketing category
- NDA
- Marketing start
- 2006-05-10
- Substance
- VARENICLINE TARTRATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CHANTIX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VARENICLINE TARTRATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82269ASB48 |
| Rxcui | 636676, 637190 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-899-05 | CHANTIX | 4200 in 1 BOTTLE | TABLET, FILM COATED | 4200 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-899 | CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20171219_b4403cea-6300-4d89-8fde-5149a80b08b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-899-05 | 43353089905 | 4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05) | 2014-03-07 | 0000-00-00 | No | No | Current |