Varenicline tartrate

Product NDC: 50090-7996
11-digit product format: 500907996
Labeler code: 50090
Product ID: 50090-7996_16973d1d-5005-4958-a34f-b00538d81c80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Varenicline tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA219106
Marketing category: ANDA
Marketing start: 2024-11-01
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 43.

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
A219106-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2024-10-29
A219106-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219106-001	AB
A219106-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219106-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-10-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219106-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-10-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A219106-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219106-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219106-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219106-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219106-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219106-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219106-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219106-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219106-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219106-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219106-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A219106-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A219106-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A219106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A219106-002	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219106-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219106-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Varenicline tartrate
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636671	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
e10d320a-adf2-4f1d-a576-9685e4551230	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Varenicline tartrate	VARENICLINE TARTRATE	A-S Medication Solutions	e10d320a-adf2-4f1d-a576-9685e4551230	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219106 application number: ANDA219106 ndc (product): 50090-7996
Varenicline	VARENICLINE TARTRATE	Florida Pharmaceutical Products, LLC	2b9c8b1e-6193-4d8e-9b50-6aca27294263	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219106 application number: ANDA219106
Varenicline tartrate	VARENICLINE TARTRATE	Indoco Remedies Limited	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219106 application number: ANDA219106

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	Marketing start	Sample	Exclude flag	Status
50090-7996-0	50090799600	56 TABLET, FILM COATED in 1 BOTTLE (50090-7996-0)	2026-06-17	No	No	Current