Varenicline

Product NDC: 0378-5090
11-digit product format: 003785090
Labeler code: 0378
Product ID: 0378-5090_5b7b6e3b-f427-4000-b252-968f3adbaa3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Varenicline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA202019
Marketing category: ANDA
Marketing start: 2024-03-14
Marketing end: 2026-07-31
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
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-5090		D	Discontinued by firm		2026-08-17
excluded package	package	0378-5090	0378-5090-73	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202019-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL			2024-02-28
A202019-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202019-002	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
2026-08-18 06:07:40	2026-07	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-02-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL		2024-02-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-02-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202019-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202019-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202019-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202019-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202019-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202019-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202019-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202019-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202019-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202019-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202019-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202019-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202019-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202019-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202019-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202019-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202019-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202019-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202019-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202019-002	AB	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202019-002	AB	1	`a50c72e98297…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-5090-73	Varenicline	56 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	56		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5090-73	EA - Each	0378-5090	a5cac72c-498b-41a3-a451-564874d78e09	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-5090	VARENICLINE TABLET, FILM COATED VARENICLINE KIT [MYLAN PHARMACEUTICALS INC.]	3	Current NDC, 1 package rows	20250501_4233fb78-ac6c-49f3-aad8-7e4bee18cac6.zip

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	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636671	varenicline 0.5 MG Oral Tablet	PSN	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636676	varenicline 1 MG Oral Tablet	PSN	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
749289	varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet Pack	PSN	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636671	varenicline 0.5 MG Oral Tablet	SCD	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636676	varenicline 1 MG Oral Tablet	SCD	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
749289	varenicline first month of therapy Pack	SY	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3
749289	varenicline starting month Pack, 53 Oral Tablets	SY	4233fb78-ac6c-49f3-aad8-7e4bee18cac6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5090-73	00378509073	56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5090-73)	2024-03-14	2026-07-31	No	No	Historical