Varenicline

Product NDC: 50090-8088
Requested package NDC: 50090-8088-0
11-digit product format: 500908088
Labeler code: 50090
Product ID: 50090-8088_9aa5b5fe-9ac9-4779-8080-c9bfd42e405b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Varenicline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA215048
Marketing category: ANDA
Marketing start: 2024-12-10
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 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
A215048-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2024-12-09
A215048-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215048-001	AB
A215048-002	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	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215048-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-12-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215048-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-09	`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	A215048-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215048-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215048-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215048-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215048-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215048-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215048-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215048-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215048-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215048-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215048-002	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215048-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215048-002	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
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
09e23664-936d-4c7f-86e5-5f924cb0c8b4	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Varenicline	VARENICLINE	A-S Medication Solutions	09e23664-936d-4c7f-86e5-5f924cb0c8b4	2026-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215048 application number: ANDA215048 ndc (package): 50090-8088-0 ndc (product): 50090-8088 ndc11 (package): 50090808800
Varenicline	VARENICLINE	Macleods Pharmaceuticals Limited	c325d582-8f43-40ea-b348-87837de97a07	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215048 application number: ANDA215048

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82269ASB48	VARENICLINE TARTRATE	375815-87-5	VARENICLINE TARTRATE
W6HS99O8ZO	VARENICLINE	249296-44-4	Varenicline

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-8088-0	50090808800	1 TABLET, FILM COATED in 1 KIT (50090-8088-0)	2026-09-21	No	No	Current