65085-0073
- Product NDC
- 65085-0073
- 11-digit product format
- 650850073
- Labeler code
- 65085
- Product ID
- 65085-0073_00532d7c-1af7-423a-b26c-5afd24e1b831
- Type
- BULK INGREDIENT
- Nonproprietary name
- VARENICLINE TARTRATE
- Dosage form
- POWDER
- Marketing category
- BULK INGREDIENT
- Marketing start
- 2021-02-15
- Substance
- VARENICLINE TARTRATE
- Active strength
- 1 kg/kg
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65085-0073 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | ||
| unfinished package | package | 65085-0073 | 65085-0073-1 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-2 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-3 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-4 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-5 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-6 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 | |
| unfinished package | package | 65085-0073 | 65085-0073-7 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-6 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-7 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-4 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-1 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-2 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-5 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65085-0073-3 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-6 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-7 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-4 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-1 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-2 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-5 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65085-0073-3 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-6 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-7 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-4 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-1 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-2 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-5 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65085-0073-3 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-6 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-7 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-4 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-1 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-2 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-5 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65085-0073-3 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-6 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-7 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-4 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-1 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-2 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-5 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65085-0073-3 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-6 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-7 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-4 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-1 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-2 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-5 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65085-0073-3 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-6 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-7 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-4 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-1 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-2 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-5 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65085-0073-3 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65085-0073-6 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65085-0073-7 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65085-0073-4 | 68b1e3bced9e… | 98a755eb8bc6… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VARENICLINE TARTRATE | 1 kg/kg |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 65085-0073-1 | 65085007301 | 1 kg in 1 DRUM (65085-0073-1) | 1 kg | 15-FEB-21 | Current |
| 65085-0073-2 | 65085007302 | 5 kg in 1 DRUM (65085-0073-2) | 5 kg | 15-FEB-21 | Current |
| 65085-0073-3 | 65085007303 | 15 kg in 1 DRUM (65085-0073-3) | 15 kg | 15-FEB-21 | Current |
| 65085-0073-4 | 65085007304 | 1 kg in 1 DRUM (65085-0073-4) | 1 kg | 15-FEB-21 | Current |
| 65085-0073-5 | 65085007305 | 5 kg in 1 DRUM (65085-0073-5) | 5 kg | 15-FEB-21 | Current |
| 65085-0073-6 | 65085007306 | 1 kg in 1 DRUM (65085-0073-6) | 1 kg | 15-FEB-21 | Current |
| 65085-0073-7 | 65085007307 | 5 kg in 1 DRUM (65085-0073-7) | 5 kg | 15-FEB-21 | Current |