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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-945		I	Inactivated by FDA		2026-09-09
excluded package	package	21695-945	21695-945-53	I	Inactivated by FDA		2026-09-09

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-945-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-945-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-945-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-945-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-945-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-945-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-945-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-945-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-945-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-945-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-945-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-945-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-945-53	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-945-53	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-945-53	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-945-53	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-945-53	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-945-53	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-945-53	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-945-53	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-945-53	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-945-53	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021928-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021928-002	AB	1	`caaa826d4ba7…`
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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f0bb1b01-df09-3a97-b952-a960743e615c	Product name	8	20260223
317a11f5-b985-4a71-b48a-5c9c00753d1c	Product name	1	20220511

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-945-53	2019-09-24	C162847	48780-1	934fe258-4959-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-945-53	CHANTIX	1 in 1 CARTON	KIT	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
varenicline tartrate	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
varenicline	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
anhydrous dibasic calcium phosphate	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-945	CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110722_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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795735	{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]	BPCK	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749289	{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack	GPCK	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749788	{56 (varenicline 1 MG Oral Tablet) } Pack	GPCK	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637188	CHANTIX 0.5 MG Oral Tablet	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637190	CHANTIX 1 MG Oral Tablet	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795735	Chantix Continuing Month Pack 1 MG 56 Count	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795737	Chantix Starting Month Pack	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636671	varenicline 0.5 MG Oral Tablet	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636676	varenicline 1 MG Oral Tablet	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749788	varenicline 1 MG Oral Tablet 56 Count Pack	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637190	varenicline 1 MG Oral Tablet [Chantix]	SBD	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636671	varenicline 0.5 MG Oral Tablet	SCD	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636676	varenicline 1 MG Oral Tablet	SCD	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637188	Chantix 0.5 MG Oral Tablet	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637190	Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
637190	Chantix 1 MG Oral Tablet	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795735	Chantix 1 MG Tablet Continuing Months Of Therapy Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795735	Chantix Continuing Months Of Therapy 1 MG Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795737	Chantix First Month of Therapy Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
795737	Chantix Starting Month PAK	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749788	varenicline 1 MG Oral Tablet 56 Count Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749788	varenicline continuing months of therapy Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749289	varenicline first month of therapy Pack	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1
749289	varenicline starting month Pack, 53 Oral Tablets	SY	b1b95503-1c7a-44e8-b5e0-d50b61db99d5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-945-53	21695094553	1 in 1 CARTON	Historical