VARENICLINE
- Product NDC
- 60505-3615
- 11-digit product format
- 605053615
- Labeler code
- 60505
- Product ID
- 60505-3615_4fb749d9-409f-d07a-7006-394063557043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VARENICLINE
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA201962
- Marketing category
- ANDA
- Marketing start
- 2024-01-15
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VARENICLINE
- 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 |
|---|---|---|---|---|---|---|
| 60505-3615-4 | VARENICLINE | 1 in 1 CARTON | KIT | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-3615-4 | EA - Each | 60505-3615 | 0f3a68a2-bfed-4ab6-b9ba-d973d108d585 | 1 | 2024-02-14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-3615 | VARENICLINE TABLET, FILM COATED VARENICLINE KIT [APOTEX CORP] | 5 | Current NDC, 1 package rows | 20250411_78d1857f-8708-5410-792f-4a3e5e7971a5.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 | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749788 | {56 (varenicline 1 MG Oral Tablet) } Pack | GPCK | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | PSN | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749788 | varenicline continuing months of therapy Pack | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749289 | varenicline first month of therapy Pack | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-3615-4 | 60505361504 | 1 KIT in 1 CARTON (60505-3615-4) * 11 TABLET, FILM COATED in 1 BLISTER PACK (60505-3606-1) * 42 TABLET, FILM COATED in 1 BLISTER PACK (60505-3607-1) | 1 kit | 2024-01-15 | No | No | Historical |