CHANTIX

Product NDC
0069-0471
Requested package NDC
0069-0471-03
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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0069-04710069-0471-03DDiscontinued by firm2026-08-11

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0069-04710069-0471-03DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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TARTRATEEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10
N021928-002CHANTIXVARENICLINE TARTRATEEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALABRLD2006-05-10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…

Additional Listing Data#

Finished product
Yes
Brand name base
CHANTIX
Listing expiration
2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82269ASB48Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636671Internal RxNorm lookup
636676Internal RxNorm lookup
637188Internal RxNorm lookup
637190Internal RxNorm lookup
749289Internal RxNorm lookup
749788Internal RxNorm lookup
795735Internal RxNorm lookup
795737Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0ff4f27-5185-4881-a749-c6b7a0ca5696Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0471-03CHANTIX1 in 1 CARTONKIT149
0069-0471-28CHANTIX1 in 1 BLISTER PACKKIT149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0471-02EA - Each0069-04712ae35096-914d-4dc4-bb61-9f58c5fdbdb012012-07-24
0069-0471-03EA - Each0069-047185bea58e-796c-401a-adf0-18a5b817f7f812015-07-20
0069-0471-28EA - Each0069-0471b88afdad-7159-410a-a696-0e37a58ef01012025-12-16
0069-0471-97EA - Each0069-04717ec42f76-1e24-45eb-8f16-57c68cccd4fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSEINACTIVE INGREDIENT029TFK992NCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TRIACETININACTIVE INGREDIENTXHX3C3X673CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
varenicline tartrateACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
vareniclineACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
anhydrous dibasic calcium phosphateINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0471CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]44Current NDC, Legacy NDC, 2 package rows20250110_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.

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
ndc (package): 0069-0471-03
ndc (product): 0069-0471
ndc11 (package): 00069047103
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]BPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188CHANTIX 0.5 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190CHANTIX 1 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix Continuing Month Pack 1 MG 56 CountPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix Starting Month PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG Oral TabletPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline 1 MG Oral Tablet 56 Count PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188varenicline 0.5 MG Oral Tablet [Chantix]SBDf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190varenicline 1 MG Oral Tablet [Chantix]SBDf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG Oral TabletSCDf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG Oral TabletSCDf0ff4f27-5185-4881-a749-c6b7a0ca569649
637188Chantix 0.5 MG Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
637190Chantix 1 MG Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795735Chantix Continuing Months Of Therapy 1 MG PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix First Month of Therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737Chantix Starting Month PAKSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline 1 MG Oral Tablet 56 Count PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749788varenicline continuing months of therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline first month of therapy PackSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
749289varenicline starting month Pack, 53 Oral TabletsSYf0ff4f27-5185-4881-a749-c6b7a0ca569649
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCK875351eb-1c25-44ad-9a37-7999192160446
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK875351eb-1c25-44ad-9a37-7999192160446
637188CHANTIX 0.5 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
637190CHANTIX 1 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
795737Chantix Starting Month PackPSN875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG Oral TabletPSN875351eb-1c25-44ad-9a37-7999192160446
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN875351eb-1c25-44ad-9a37-7999192160446
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD875351eb-1c25-44ad-9a37-7999192160446
637190varenicline 1 MG Oral Tablet [Chantix]SBD875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG Oral TabletSCD875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG Oral TabletSCD875351eb-1c25-44ad-9a37-7999192160446
637188Chantix 0.5 MG Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
637190Chantix 1 MG Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
795737Chantix First Month of Therapy PackSY875351eb-1c25-44ad-9a37-7999192160446
795737Chantix Starting Month PAKSY875351eb-1c25-44ad-9a37-7999192160446
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY875351eb-1c25-44ad-9a37-7999192160446
749289varenicline first month of therapy PackSY875351eb-1c25-44ad-9a37-7999192160446
749289varenicline starting month Pack, 53 Oral TabletsSY875351eb-1c25-44ad-9a37-7999192160446
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCK0fefd790-b526-4f2f-8c83-5f39f73065564
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK0fefd790-b526-4f2f-8c83-5f39f73065564
637188CHANTIX 0.5 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
637190CHANTIX 1 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix Starting Month PackPSN0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN0fefd790-b526-4f2f-8c83-5f39f73065564
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD0fefd790-b526-4f2f-8c83-5f39f73065564
637190varenicline 1 MG Oral Tablet [Chantix]SBD0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG Oral TabletSCD0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG Oral TabletSCD0fefd790-b526-4f2f-8c83-5f39f73065564
637188Chantix 0.5 MG Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
637190Chantix 1 MG Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix First Month of Therapy PackSY0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix Starting Month PAKSY0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline first month of therapy PackSY0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline starting month Pack, 53 Oral TabletsSY0fefd790-b526-4f2f-8c83-5f39f73065564
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCK826c77fa-d8b2-48df-8028-720b15912d922
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCK826c77fa-d8b2-48df-8028-720b15912d922
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK826c77fa-d8b2-48df-8028-720b15912d922
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK826c77fa-d8b2-48df-8028-720b15912d922
637188CHANTIX 0.5 MG Oral TabletPSN826c77fa-d8b2-48df-8028-720b15912d922
637190CHANTIX 1 MG Oral TabletPSN826c77fa-d8b2-48df-8028-720b15912d922
795735Chantix Continuing Month Pack 1 MG 56 CountPSN826c77fa-d8b2-48df-8028-720b15912d922
795737Chantix Starting Month PackPSN826c77fa-d8b2-48df-8028-720b15912d922
636671varenicline 0.5 MG Oral TabletPSN826c77fa-d8b2-48df-8028-720b15912d922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0471-03000690471031 KIT in 1 CARTON (0069-0471-03) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK1 kit2006-05-100000-00-00NoNoCurrent