Varenicline tartrate
- Product NDC
- 42571-475
- 11-digit product format
- 425710475
- Labeler code
- 42571
- Product ID
- 42571-475_426f1bdc-211b-b246-e063-6394a90a8de3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Varenicline tartrate
- Dosage form
- KIT
- Labeler
- Micro Labs Limited
- Application
- ANDA218302
- Marketing category
- ANDA
- Marketing start
- 2025-12-01
- 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 |
|---|---|
| Unii | 82269ASB48 |
| Rxcui | 636671, 636676, 749289, 749788 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f0bb1b01-df09-3a97-b952-a960743e615c | Product name | 8 | 20260223 |
| 317a11f5-b985-4a71-b48a-5c9c00753d1c | Product name | 1 | 20220511 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42571-475-84 | Varenicline tartrate | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749289 | {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack | GPCK | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749788 | {56 (varenicline 1 MG Oral Tablet) } Pack | GPCK | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | PSN | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749788 | varenicline continuing months of therapy Pack | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749289 | varenicline first month of therapy Pack | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42571-475-84 | 42571047584 | 1 KIT in 1 CARTON (42571-475-84) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2025-12-01 | No | No | Current |