varenicline

Product NDC: 42291-928
11-digit product format: 422910928
Labeler code: 42291
Product ID: 42291-928_48bfad2d-97de-5ed7-e063-6394a90a2e86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA214557
Marketing category: ANDA
Marketing start: 2023-09-14
Substance: VARENICLINE TARTRATE
Active strength: 1 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
A214557-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2023-08-23
A214557-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2023-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214557-001	AB
A214557-002	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
2026-02-19 14:30 UTC	2026-02	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214557-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-08-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214557-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-08-23	`a50c72e98297…`

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	A214557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214557-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214557-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214557-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214557-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214557-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214557-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214557-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214557-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214557-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214557-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214557-002	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214557-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214557-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: varenicline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VARENICLINE TARTRATE	1 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
0552d7ff-9fe8-9c9f-e063-6394a90a79fe	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42291-928-56	varenicline	56 in 1 BOTTLE	TABLET, FILM COATED	56		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-928-56	EA - Each	42291-928	8a4a849d-c3ce-4c33-bd22-ceaccdee873e	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-928	VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [AVKARE]	1	Current NDC, 1 package rows	20230915_0552d7ff-9fe8-9c9f-e063-6394a90a79fe.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
varenicline	VARENICLINE TARTRATE	AvKARE	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214557 application number: ANDA214557 ndc (product): 42291-928
varenicline	VARENICLINE TARTRATE	A-S Medication Solutions	6351047a-9896-4a30-8e49-4d306ce9c9c0	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214557 application number: ANDA214557
varenicline	VARENICLINE TARTRATE	A-S Medication Solutions	2d5dfa6e-e69d-414a-8ff2-44714debbbe2	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214557 application number: ANDA214557
varenicline	VARENICLINE TARTRATE	Major Pharmaceuticals	1297c291-da28-4a73-9c28-d5adee36d7b7	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214557 application number: ANDA214557
varenicline	VARENICLINE TARTRATE	Ascend Laboratories, LLC	e22e2a6a-66b4-459c-b978-51700e31a1a9	2023-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214557 application number: ANDA214557

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	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636671	varenicline 0.5 MG Oral Tablet	PSN	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636676	varenicline 1 MG Oral Tablet	PSN	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636671	varenicline 0.5 MG Oral Tablet	SCD	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636676	varenicline 1 MG Oral Tablet	SCD	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
749289	varenicline first month of therapy Pack	SY	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2
749289	varenicline starting month Pack, 53 Oral Tablets	SY	0552d7ff-9fe8-9c9f-e063-6394a90a79fe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42291-928-56	42291092856	56 TABLET, FILM COATED in 1 BOTTLE (42291-928-56)	2023-09-14	No	No	Current