CHANTIX
- Product NDC
- 0069-0471
- 11-digit product format
- 000690471
- Labeler code
- 0069
- Product ID
- 0069-0471_09cce88b-e4f0-48b7-ac05-54d97976b4c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- varenicline tartrate
- Dosage form
- KIT
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA021928
- Marketing category
- NDA
- Marketing start
- 2006-05-10
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0069-0471 | 0069-0471-03 | D | Discontinued by firm | 2026-08-11 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0069-0471 | 0069-0471-03 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021928-001 | CHANTIX | VARENICLINE TARTRATE | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 |
| N021928-002 | CHANTIX | VARENICLINE TARTRATE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021928-001 | AB |
| N021928-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB | RLD | 2006-05-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021928-001 | CHANTIX | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021928-002 | CHANTIX | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2006-05-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | RLD | 2006-05-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | RLD | 2006-05-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | RLD | 2006-05-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | RLD, RS | 2006-05-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-10 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-001 | CHANTIX | EQ 0.5MG BASE | TABLET / ORAL | AB | RLD | 2006-05-10 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-002 | CHANTIX | EQ 1MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-05-10 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021928-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021928-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021928-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021928-002 | AB | 1 | 31067a03dcf5… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-002 | AB | 1 | 782e0a99824c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021928-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021928-002 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | 6890927*PED | 2022-11-06 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | 7265119*PED | 2023-02-03 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | 6890927*PED | 2022-11-06 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | 7265119*PED | 2023-02-03 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | 6890927*PED | 2022-11-06 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | 7265119*PED | 2023-02-03 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | 6890927*PED | 2022-11-06 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | 7265119*PED | 2023-02-03 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | 6890927*PED | 2022-11-06 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | 7265119*PED | 2023-02-03 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | 6890927*PED | 2022-11-06 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | 7265119*PED | 2023-02-03 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 6410550 | 2020-05-10 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 6410550*PED | 2020-11-10 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 6890927*PED | 2022-11-06 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | 7265119*PED | 2023-02-03 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 6410550 | 2020-05-10 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 6410550*PED | 2020-11-10 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 6890927*PED | 2022-11-06 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | 7265119*PED | 2023-02-03 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | 6890927 | 2022-05-06 | U-56 | Drug substance, Drug product | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | 7265119 | 2022-08-03 | U-56 | Drug substance, Drug product | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | 6890927*PED | 2022-11-06 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | 7265119*PED | 2023-02-03 | Pediatric extension | bb7c543d1eb4… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | M-237 | 2022-02-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-001 | PED | 2022-08-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | M-237 | 2022-02-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021928-002 | PED | 2022-08-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | M-237 | 2022-02-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-001 | PED | 2022-08-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | M-237 | 2022-02-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021928-002 | PED | 2022-08-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | M-237 | 2022-02-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-001 | PED | 2022-08-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | M-237 | 2022-02-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021928-002 | PED | 2022-08-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | M-183 | 2019-08-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | M-192 | 2019-12-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | PED | 2020-02-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | PED | 2020-06-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | M-237 | 2022-02-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-001 | PED | 2022-08-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | M-183 | 2019-08-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | M-192 | 2019-12-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | PED | 2020-02-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | PED | 2020-06-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | M-237 | 2022-02-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021928-002 | PED | 2022-08-22 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | M-237 | 2022-02-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-001 | PED | 2022-08-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-002 | M-237 | 2022-02-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021928-002 | PED | 2022-08-22 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-001 | M-237 | 2022-02-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-001 | PED | 2022-08-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-002 | M-237 | 2022-02-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021928-002 | PED | 2022-08-22 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021928-001 | M-237 | 2022-02-22 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021928-001 | PED | 2022-08-22 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021928-002 | M-237 | 2022-02-22 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021928-002 | PED | 2022-08-22 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021928-001 | M-237 | 2022-02-22 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021928-001 | PED | 2022-08-22 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021928-002 | M-237 | 2022-02-22 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021928-002 | PED | 2022-08-22 | 5aa47cf7b7d7… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CHANTIX
- Listing expiration
- 2027-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82269ASB48 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f0ff4f27-5185-4881-a749-c6b7a0ca5696 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0069-0471-03 | CHANTIX | 1 in 1 CARTON | KIT | 1 | 49 | |
| 0069-0471-28 | CHANTIX | 1 in 1 BLISTER PACK | KIT | 1 | 49 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-0471-02 | EA - Each | 0069-0471 | 2ae35096-914d-4dc4-bb61-9f58c5fdbdb0 | 1 | 2012-07-24 |
| 0069-0471-03 | EA - Each | 0069-0471 | 85bea58e-796c-401a-adf0-18a5b817f7f8 | 1 | 2015-07-20 |
| 0069-0471-28 | EA - Each | 0069-0471 | b88afdad-7159-410a-a696-0e37a58ef010 | 1 | 2025-12-16 |
| 0069-0471-97 | EA - Each | 0069-0471 | 7ec42f76-1e24-45eb-8f16-57c68cccd4fe | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0069-0471 | CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC] | 44 | Current NDC, Legacy NDC, 2 package rows | 20250110_f0ff4f27-5185-4881-a749-c6b7a0ca5696.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CHANTIX | VARENICLINE TARTRATE | Pfizer Laboratories Div Pfizer Inc | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 2026-01-23 | Warnings, Adverse reactions | 021928 NDA021928 0069-0471 |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 021928 NDA021928 |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | f22e3aef-714b-4014-8d77-83ee03fd1f57 | 2020-01-01 | Warnings, Adverse reactions | 021928 NDA021928 |
| CHANTIX | VARENICLINE TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | b4403cea-6300-4d89-8fde-5149a80b08b9 | 2017-12-18 | Warnings, Adverse reactions | 021928 NDA021928 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 795737 | {11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy] | BPCK | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795735 | {56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy] | BPCK | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749289 | {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack | GPCK | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749788 | {56 (varenicline 1 MG Oral Tablet) } Pack | GPCK | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637188 | CHANTIX 0.5 MG Oral Tablet | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637190 | CHANTIX 1 MG Oral Tablet | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795735 | Chantix Continuing Month Pack 1 MG 56 Count | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795737 | Chantix Starting Month Pack | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637188 | varenicline 0.5 MG Oral Tablet [Chantix] | SBD | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637190 | varenicline 1 MG Oral Tablet [Chantix] | SBD | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637188 | Chantix 0.5 MG Oral Tablet | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637190 | Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 637190 | Chantix 1 MG Oral Tablet | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795735 | Chantix 1 MG Tablet Continuing Months Of Therapy Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795735 | Chantix Continuing Months Of Therapy 1 MG Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795737 | Chantix First Month of Therapy Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795737 | Chantix Starting Month PAK | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749788 | varenicline 1 MG Oral Tablet 56 Count Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749788 | varenicline continuing months of therapy Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749289 | varenicline first month of therapy Pack | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 49 |
| 795737 | {11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy] | BPCK | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 749289 | {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack | GPCK | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637188 | CHANTIX 0.5 MG Oral Tablet | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637190 | CHANTIX 1 MG Oral Tablet | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 795737 | Chantix Starting Month Pack | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637188 | varenicline 0.5 MG Oral Tablet [Chantix] | SBD | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637190 | varenicline 1 MG Oral Tablet [Chantix] | SBD | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637188 | Chantix 0.5 MG Oral Tablet | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637190 | Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 637190 | Chantix 1 MG Oral Tablet | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 795737 | Chantix First Month of Therapy Pack | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 795737 | Chantix Starting Month PAK | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 749289 | varenicline first month of therapy Pack | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | 875351eb-1c25-44ad-9a37-799919216044 | 6 |
| 795737 | {11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy] | BPCK | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 749289 | {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack | GPCK | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637188 | CHANTIX 0.5 MG Oral Tablet | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637190 | CHANTIX 1 MG Oral Tablet | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 795737 | Chantix Starting Month Pack | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636676 | varenicline 1 MG Oral Tablet | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 749289 | varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack | PSN | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637188 | varenicline 0.5 MG Oral Tablet [Chantix] | SBD | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637190 | varenicline 1 MG Oral Tablet [Chantix] | SBD | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636671 | varenicline 0.5 MG Oral Tablet | SCD | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636676 | varenicline 1 MG Oral Tablet | SCD | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637188 | Chantix 0.5 MG Oral Tablet | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637190 | Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 637190 | Chantix 1 MG Oral Tablet | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 795737 | Chantix First Month of Therapy Pack | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 795737 | Chantix Starting Month PAK | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636671 | varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 636676 | varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 749289 | varenicline first month of therapy Pack | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 749289 | varenicline starting month Pack, 53 Oral Tablets | SY | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 4 |
| 795737 | {11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy] | BPCK | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 795735 | {56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy] | BPCK | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 749289 | {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack | GPCK | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 749788 | {56 (varenicline 1 MG Oral Tablet) } Pack | GPCK | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 637188 | CHANTIX 0.5 MG Oral Tablet | PSN | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 637190 | CHANTIX 1 MG Oral Tablet | PSN | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 795735 | Chantix Continuing Month Pack 1 MG 56 Count | PSN | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 795737 | Chantix Starting Month Pack | PSN | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
| 636671 | varenicline 0.5 MG Oral Tablet | PSN | 826c77fa-d8b2-48df-8028-720b15912d92 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0069-0471-03 | 00069047103 | 1 KIT in 1 CARTON (0069-0471-03) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2006-05-10 | 0000-00-00 | No | No | Current |
| 0069-0471-28 | 00069047128 | 1 KIT in 1 BLISTER PACK (0069-0471-28) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2025-09-22 | No | No | Current |