CHANTIX

Product NDC
21695-945
11-digit product format
216950945
Labeler code
21695
Product ID
21695-945_b1b95503-1c7a-44e8-b5e0-d50b61db99d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
KIT
Labeler
Rebel Distributors Corp
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-945IInactivated by FDA2026-08-11
excluded packagepackage21695-94521695-945-53IInactivated by FDA2026-08-11

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.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-945-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-945-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-945-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-945-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-945-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-945-53cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-945-53302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-945-53ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-945-530efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-945-53ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-945-53367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-945-53557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-945-538af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-945-53834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-945-531332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-945-53fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-945-5386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-945-53bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-945-538dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-945-53e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-945-539bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-945-53110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021928-001CHANTIXVARENICLINE TARTRATEEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10
N021928-002CHANTIXVARENICLINE TARTRATEEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021928-001AB
N021928-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021928-001CHANTIXEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021928-002CHANTIXEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALRLD2006-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002CHANTIXEQ 1MG BASETABLET / ORALRLD2006-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD2006-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD2006-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALRLD2006-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002CHANTIXEQ 1MG BASETABLET / ORALRLD, RS2006-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD, RS2006-05-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021928-001CHANTIXEQ 0.5MG BASETABLET / ORALABRLD2006-05-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002CHANTIXEQ 1MG BASETABLET / ORALABRLD, RS2006-05-10782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021928-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021928-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021928-002AB131067a03dcf5…
2022-04-08 23:34 UTC2022-04N021928-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021928-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021928-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002AB1782e0a99824c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021928-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021928-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00168909272022-05-06U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00172651192022-08-03U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0016890927*PED2022-11-06Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0017265119*PED2023-02-03Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00268909272022-05-06U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-00272651192022-08-03U-56Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0026890927*PED2022-11-06Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-0027265119*PED2023-02-03Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-00168909272022-05-06U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00172651192022-08-03U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0016890927*PED2022-11-06Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0017265119*PED2023-02-03Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00268909272022-05-06U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-00272651192022-08-03U-56Drug substance, Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0026890927*PED2022-11-06Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-0027265119*PED2023-02-03Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-00168909272022-05-06U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00172651192022-08-03U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0016890927*PED2022-11-06Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0017265119*PED2023-02-03Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00268909272022-05-06U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-00272651192022-08-03U-56Drug substance, Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0026890927*PED2022-11-06Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-0027265119*PED2023-02-03Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-00164105502020-05-10U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0016410550*PED2020-11-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00168909272022-05-06U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00172651192022-08-03U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0016890927*PED2022-11-06Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0017265119*PED2023-02-03Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00264105502020-05-10U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0026410550*PED2020-11-10Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00268909272022-05-06U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-00272651192022-08-03U-56Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0026890927*PED2022-11-06Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-0027265119*PED2023-02-03Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021928-00168909272022-05-06U-56Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-00172651192022-08-03U-56Drug substance, Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-0016890927*PED2022-11-06Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-0017265119*PED2023-02-03Pediatric extensionbb7c543d1eb4…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001M-2372022-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-001PED2022-08-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002M-2372022-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021928-002PED2022-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021928-001M-2372022-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-001PED2022-08-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002M-2372022-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021928-002PED2022-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021928-001M-2372022-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-001PED2022-08-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002M-2372022-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021928-002PED2022-08-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021928-001M-1832019-08-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001M-1922019-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2020-02-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2020-06-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001M-2372022-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-001PED2022-08-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-1832019-08-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-1922019-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2020-02-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2020-06-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002M-2372022-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021928-002PED2022-08-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021928-001M-2372022-02-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-001PED2022-08-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002M-2372022-02-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021928-002PED2022-08-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021928-001M-2372022-02-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-001PED2022-08-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002M-2372022-02-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021928-002PED2022-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-001M-2372022-02-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-001PED2022-08-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-002M-2372022-02-2287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021928-002PED2022-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N021928-001M-2372022-02-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-001PED2022-08-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-002M-2372022-02-225aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021928-002PED2022-08-225aa47cf7b7d7…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-945-53CHANTIX1 in 1 CARTONKIT11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-945CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110722_b1b95503-1c7a-44e8-b5e0-d50b61db99d5.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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHANTIXVARENICLINE TARTRATEPfizer Laboratories Div Pfizer Incf0ff4f27-5185-4881-a749-c6b7a0ca56962026-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021928
application number: NDA021928
CHANTIXVARENICLINE TARTRATEProficient Rx LP0fefd790-b526-4f2f-8c83-5f39f73065562020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021928
application number: NDA021928
CHANTIXVARENICLINE TARTRATEProficient Rx LPf22e3aef-714b-4014-8d77-83ee03fd1f572020-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021928
application number: NDA021928
CHANTIXVARENICLINE TARTRATEAphena Pharma Solutions - Tennessee, LLCb4403cea-6300-4d89-8fde-5149a80b08b92017-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021928
application number: NDA021928

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188CHANTIX 0.5 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190CHANTIX 1 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix Continuing Month Pack 1 MG 56 CountPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix Starting Month PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG Oral TabletPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline 1 MG Oral Tablet 56 Count PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188varenicline 0.5 MG Oral Tablet [Chantix]SBDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190varenicline 1 MG Oral Tablet [Chantix]SBDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG Oral TabletSCDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG Oral TabletSCDb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637188Chantix 0.5 MG Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
637190Chantix 1 MG Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795735Chantix Continuing Months Of Therapy 1 MG PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix First Month of Therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
795737Chantix Starting Month PAKSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline 1 MG Oral Tablet 56 Count PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749788varenicline continuing months of therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline first month of therapy PackSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51
749289varenicline starting month Pack, 53 Oral TabletsSYb1b95503-1c7a-44e8-b5e0-d50b61db99d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-945-53216950945531 in 1 CARTONHistorical