CHANTIX

Product NDC: 0069-0468
11-digit product format: 000690468
Labeler code: 0069
Product ID: 0069-0468_09cce88b-e4f0-48b7-ac05-54d97976b4c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA021928
Marketing category: NDA
Marketing start: 2006-05-10
Substance: VARENICLINE TARTRATE
Active strength: .5 mg/1
Pharmacologic classes: Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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CHANTIX	VARENICLINE TARTRATE	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10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CHANTIX	VARENICLINE TARTRATE	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10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UTC	2026-02	N021928-001	CHANTIX	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD	2006-05-10	`011fe1cb6892…`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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VARENICLINE TARTRATE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82269ASB48	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 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
749788	Internal RxNorm lookup
795735	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
f0ff4f27-5185-4881-a749-c6b7a0ca5696	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
0069-0468-56	CHANTIX	56 in 1 BOTTLE	TABLET, FILM COATED	56		49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0468-56	EA - Each	0069-0468	748011c6-6ede-427b-a7f6-28f8daace2bd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARENICLINE TARTRATE	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
VARENICLINE	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
CROSCARMELLOSE	INACTIVE INGREDIENT	029TFK992N	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	28
VARENICLINE TARTRATE	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
VARENICLINE	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
varenicline tartrate	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
varenicline	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
anhydrous dibasic calcium phosphate	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	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
0069-0468	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]	44	Current NDC, Legacy NDC, 1 package rows	20250110_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
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 ndc (product): 0069-0468
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	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795735	{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]	BPCK	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749289	{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack	GPCK	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749788	{56 (varenicline 1 MG Oral Tablet) } Pack	GPCK	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637188	CHANTIX 0.5 MG Oral Tablet	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637190	CHANTIX 1 MG Oral Tablet	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795735	Chantix Continuing Month Pack 1 MG 56 Count	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795737	Chantix Starting Month Pack	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636671	varenicline 0.5 MG Oral Tablet	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636676	varenicline 1 MG Oral Tablet	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749788	varenicline 1 MG Oral Tablet 56 Count Pack	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637190	varenicline 1 MG Oral Tablet [Chantix]	SBD	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636671	varenicline 0.5 MG Oral Tablet	SCD	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636676	varenicline 1 MG Oral Tablet	SCD	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637188	Chantix 0.5 MG Oral Tablet	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637190	Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637190	Chantix 1 MG Oral Tablet	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795735	Chantix 1 MG Tablet Continuing Months Of Therapy Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795735	Chantix Continuing Months Of Therapy 1 MG Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795737	Chantix First Month of Therapy Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
795737	Chantix Starting Month PAK	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749788	varenicline 1 MG Oral Tablet 56 Count Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749788	varenicline continuing months of therapy Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749289	varenicline first month of therapy Pack	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
749289	varenicline starting month Pack, 53 Oral Tablets	SY	f0ff4f27-5185-4881-a749-c6b7a0ca5696	49
637188	CHANTIX 0.5 MG Oral Tablet	PSN	9a0d0273-8099-420a-b4e1-097153a4aecb	3
636671	varenicline 0.5 MG Oral Tablet	PSN	9a0d0273-8099-420a-b4e1-097153a4aecb	3
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	9a0d0273-8099-420a-b4e1-097153a4aecb	3
636671	varenicline 0.5 MG Oral Tablet	SCD	9a0d0273-8099-420a-b4e1-097153a4aecb	3
637188	Chantix 0.5 MG Oral Tablet	SY	9a0d0273-8099-420a-b4e1-097153a4aecb	3
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	9a0d0273-8099-420a-b4e1-097153a4aecb	3
637188	CHANTIX 0.5 MG Oral Tablet	PSN	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
636671	varenicline 0.5 MG Oral Tablet	PSN	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
636671	varenicline 0.5 MG Oral Tablet	SCD	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
637188	Chantix 0.5 MG Oral Tablet	SY	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	4aa4019c-737f-4906-bfd9-ca37a74e7c40	2
637188	CHANTIX 0.5 MG Oral Tablet	PSN	f990eca6-fe6f-4423-a118-4b7b970995a1	1
637188	CHANTIX 0.5 MG Oral Tablet	PSN	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1
636671	varenicline 0.5 MG Oral Tablet	PSN	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1
636671	varenicline 0.5 MG Oral Tablet	PSN	f990eca6-fe6f-4423-a118-4b7b970995a1	1
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1
637188	varenicline 0.5 MG Oral Tablet [Chantix]	SBD	f990eca6-fe6f-4423-a118-4b7b970995a1	1
636671	varenicline 0.5 MG Oral Tablet	SCD	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1
636671	varenicline 0.5 MG Oral Tablet	SCD	f990eca6-fe6f-4423-a118-4b7b970995a1	1
637188	Chantix 0.5 MG Oral Tablet	SY	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1
637188	Chantix 0.5 MG Oral Tablet	SY	f990eca6-fe6f-4423-a118-4b7b970995a1	1
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	f990eca6-fe6f-4423-a118-4b7b970995a1	1
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	1053cbe5-dc3d-4d95-93de-0022a22a6ed1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-0468-56	00069046856	56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)	2006-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHANTIX	Pfizer Laboratories Div Pfizer Inc \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Italia S.r.l. \| Pfizer Manufacturing Deutschland GmbH	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	49
CHANTIX	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
CHANTIX	A-S Medication Solutions	2018-08-02	HUMAN PRESCRIPTION DRUG LABEL	1
CHANTIX	Avera McKennan Hospital	2017-03-15	HUMAN PRESCRIPTION DRUG LABEL	1
CHANTIX	Carilion Materials Management	2014-06-03	HUMAN PRESCRIPTION DRUG LABEL	2
Chantix	Rebel Distributors Corp	2010-09-23	HUMAN PRESCRIPTION DRUG LABEL	1