Varenicline tartrate

Product NDC: 14445-153
Requested package NDC: 14445-153-56
11-digit product format: 144450153
Labeler code: 14445
Product ID: 14445-153_97b537d2-8829-42ad-86e9-8523b4430843
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Varenicline tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Indoco Remedies Limited
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: 2026-12-31
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: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636671	Internal RxNorm lookup
636676	Internal RxNorm lookup
749289	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
cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	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
14445-153-56	Varenicline tartrate	56 in 1 BOTTLE	TABLET, FILM COATED	56		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14445-153	VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [INDOCO REMEDIES LIMITED ]	3	Current NDC, 1 package rows	20241105_cd83bc6c-20f4-42e1-adb4-a3d1d89413f4.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 · 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
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 ndc (package): 14445-153-56 ndc (product): 14445-153 ndc11 (package): 14445015356

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
749289	{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack	GPCK	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636671	varenicline 0.5 MG Oral Tablet	PSN	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636676	varenicline 1 MG Oral Tablet	PSN	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636671	varenicline 0.5 MG Oral Tablet	SCD	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636676	varenicline 1 MG Oral Tablet	SCD	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
749289	varenicline first month of therapy Pack	SY	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3
749289	varenicline starting month Pack, 53 Oral Tablets	SY	cd83bc6c-20f4-42e1-adb4-a3d1d89413f4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
14445-153-56	14445015356	56 TABLET, FILM COATED in 1 BOTTLE (14445-153-56)	2024-11-01	No	No	Current