CHANTIX

Product NDC: 63539-473
Requested package NDC: 63539-473-10
11-digit product format: 635390473
Labeler code: 63539
Product ID: 63539-473_95c277e4-83d1-4900-a882-792c1e6a4092
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline tartrate
Dosage form: KIT
Labeler: U.S. Pharmaceuticals
Application: NDA021928
Marketing category: NDA
Marketing start: 2006-05-10
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63539-473	63539-473-10	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.

Historic NDC status page 1 of 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-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#

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

Application-product, TE code table
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
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 table
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#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	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#

Exclusivity history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARENICLINE TARTRATE	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
VARENICLINE	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
CROSCARMELLOSE	INACTIVE INGREDIENT	029TFK992N	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHANTIX (VARENICLINE TARTRATE) KIT [U.S. PHARMACEUTICALS]	3

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
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	Exact identifier application applno (NDA): 021928 application number: NDA021928
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	0fefd790-b526-4f2f-8c83-5f39f7306556	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928
CHANTIX	VARENICLINE TARTRATE	Proficient Rx LP	f22e3aef-714b-4014-8d77-83ee03fd1f57	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928
CHANTIX	VARENICLINE TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b4403cea-6300-4d89-8fde-5149a80b08b9	2017-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021928 application number: NDA021928

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82269ASB48	VARENICLINE TARTRATE	375815-87-5	varenicline tartrate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-473-10	63539047310	1 KIT in 1 CARTON (63539-473-10) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2006-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHANTIX	U.S. Pharmaceuticals \| Pfizer Ireland Pharmaceuticals \| Pfizer Italia S.r.l. \| Pfizer Manufacturing Deutschland GmbH \| Upjohn Manufacturing Ireland Unlimited Company	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	9