CHANTIX

Product NDC: 63187-618
11-digit product format: 631870618
Labeler code: 63187
Product ID: 63187-618_1da9a839-db61-41e9-a214-d007b8f59820
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline tartrate
Dosage form: KIT
Labeler: Proficient Rx LP
Application: NDA021928
Marketing category: NDA
Marketing start: 2006-05-10
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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CHANTIX	VARENICLINE TARTRATE	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10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CHANTIX	VARENICLINE TARTRATE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10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UTC	2026-02	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`011fe1cb6892…`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UTC	2026-02	N021928-002	CHANTIX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`011fe1cb6892…`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: CHANTIX
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0fefd790-b526-4f2f-8c83-5f39f7306556	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-618-53	CHANTIX	1 in 1 CARTON	KIT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-618	CHANTIX (VARENICLINE TARTRATE) KIT [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 1 package rows	20200218_0fefd790-b526-4f2f-8c83-5f39f7306556.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 ndc (product): 63187-618
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	0fefd790-b526-4f2f-8c83-5f39f7306556	4
749289	{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack	GPCK	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637188	CHANTIX 0.5 MG Oral Tablet	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637190	CHANTIX 1 MG Oral Tablet	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
795737	Chantix Starting Month Pack	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636671	varenicline 0.5 MG Oral Tablet	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636676	varenicline 1 MG Oral Tablet	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637190	varenicline 1 MG Oral Tablet [Chantix]	SBD	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636671	varenicline 0.5 MG Oral Tablet	SCD	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636676	varenicline 1 MG Oral Tablet	SCD	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637188	Chantix 0.5 MG Oral Tablet	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637190	Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
637190	Chantix 1 MG Oral Tablet	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
795737	Chantix First Month of Therapy Pack	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
795737	Chantix Starting Month PAK	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
749289	varenicline first month of therapy Pack	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4
749289	varenicline starting month Pack, 53 Oral Tablets	SY	0fefd790-b526-4f2f-8c83-5f39f7306556	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-618-53	63187061853	1 KIT in 1 CARTON (63187-618-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2018-12-01	0000-00-00	No	No	Current