varenicline

Product NDC: 75834-335
11-digit product format: 758340335
Labeler code: 75834
Product ID: 75834-335_077ec752-4145-4592-9ee1-6fdc9a04795a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Nivagen Pharmaceuticals Inc.
Application: ANDA217115
Marketing category: ANDA
Marketing start: 2026-03-02
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
A217115-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2024-07-23
A217115-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217115-001	AB
A217115-002	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	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL		2024-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-07-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-07-23	`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	A217115-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217115-002	AB	1	`011fe1cb6892…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217115-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217115-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217115-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217115-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217115-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217115-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217115-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217115-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217115-002	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
077ec752-4145-4592-9ee1-6fdc9a04795a	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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-335-27	varenicline	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
75834-335-27	varenicline	4 in 1 CARTON	TABLET, FILM COATED	4	1
75834-335-28	varenicline	56 in 1 BOTTLE	TABLET, FILM COATED	56	1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
varenicline	VARENICLINE	Nivagen Pharmaceuticals Inc.	077ec752-4145-4592-9ee1-6fdc9a04795a	2025-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217115 application number: ANDA217115 ndc (product): 75834-335

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

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	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636671	varenicline 0.5 MG Oral Tablet	PSN	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636676	varenicline 1 MG Oral Tablet	PSN	077ec752-4145-4592-9ee1-6fdc9a04795a	1
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636671	varenicline 0.5 MG Oral Tablet	SCD	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636676	varenicline 1 MG Oral Tablet	SCD	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	077ec752-4145-4592-9ee1-6fdc9a04795a	1
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	077ec752-4145-4592-9ee1-6fdc9a04795a	1
749289	varenicline first month of therapy Pack	SY	077ec752-4145-4592-9ee1-6fdc9a04795a	1
749289	varenicline starting month Pack, 53 Oral Tablets	SY	077ec752-4145-4592-9ee1-6fdc9a04795a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
75834-335-27	75834033527	4 BLISTER PACK in 1 CARTON (75834-335-27) / 14 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	2026-03-02	No	No	Current
75834-335-28	75834033528	56 TABLET, FILM COATED in 1 BOTTLE (75834-335-28)		2026-03-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
varenicline	Nivagen Pharmaceuticals Inc. \| Piramal Pharma Limited	2025-08-31	Human Prescription Drug Label	1