varenicline tartrate
- Product NDC
- 68462-895
- 11-digit product format
- 684620895
- Labeler code
- 68462
- Product ID
- 68462-895_67a82933-5f10-4a9a-8605-d09cd2f08d52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline tartrate
- Dosage form
- KIT
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA214255
- Marketing category
- ANDA
- Marketing start
- 2023-08-22
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- varenicline tartrate
- Listing expiration
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| 68462-895-04 | varenicline tartrate | 1 in 1 CARTON | KIT | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-895-04 | EA - Each | 68462-895 | fe2e791e-6f87-4432-8980-668993aa85e5 | 1 | 2023-10-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68462-895 | VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE (VARENICLINE TARTRATE) KIT [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, 1 package rows | 20230826_e8a06e8e-1938-412c-a98a-28f0a29fe3ac.zip |
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 | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749788 | {56 (varenicline 1 MG Oral Tablet) } Pack | GPCK | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | PSN | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749788 | varenicline continuing months of therapy Pack | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749289 | varenicline first month of therapy Pack | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68462-895-04 | 68462089504 | 1 KIT in 1 CARTON (68462-895-04) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2023-08-22 | No | No | Historical |