varenicline
- Product NDC
- 75834-336
- 11-digit product format
- 758340336
- Labeler code
- 75834
- Product ID
- 75834-336_077ec752-4145-4592-9ee1-6fdc9a04795a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline
- Dosage form
- KIT
- Labeler
- Nivagen Pharmaceuticals Inc.
- Application
- ANDA217115
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- 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 |
|---|---|
| Unii | 82269ASB48 |
| Rxcui | 636671, 636676, 749289 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f0bb1b01-df09-3a97-b952-a960743e615c | Product name | 8 | 20260223 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 317a11f5-b985-4a71-b48a-5c9c00753d1c | Product name | 1 | 20220511 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75834-336-24 | varenicline | 1 in 1 BOX | KIT | 1 | 1 | |
| 75834-336-24 | varenicline | 2 in 1 KIT | KIT | 2 | 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 | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 749289 | varenicline first month of therapy Pack | SY | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | 077ec752-4145-4592-9ee1-6fdc9a04795a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75834-336-24 | 75834033624 | 2 BOX in 1 KIT (75834-336-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (75834-334-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (75834-335-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2 box | 2026-03-02 | No | No | Historical |