Varenicline Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-09-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:53:29

Label at a glance#

ProductVarenicline

Active ingredientVARENICLINE TARTRATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1773-6

Varenicline Tablets, 0.5 mg

56 Tablets

Rx only

NDC 70771-1774-6

Varenicline Tablets, 1 mg

56 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
636671	varenicline 0.5 MG Oral Tablet	PSN	2
636676	varenicline 1 MG Oral Tablet	PSN	2
636671	varenicline 0.5 MG Oral Tablet	SCD	2
636676	varenicline 1 MG Oral Tablet	SCD	2
636671	varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet	SY	2
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
VARENICLINE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20220322

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
70771-1773-6	Varenicline	56 in 1 BOTTLE	TABLET, FILM COATED	56		2
70771-1774-6	Varenicline	56 in 1 BOTTLE	TABLET, FILM COATED	56		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1773	VARENICLINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 1 package rows	20230928_481b94af-ee34-44be-8ca1-b2415525efac.zip
70771-1774	VARENICLINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 1 package rows	20230928_481b94af-ee34-44be-8ca1-b2415525efac.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Varenicline
VARENICLINE TARTRATE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 1 ALUMINUM LAKE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1773	70771-1773-6
70771-1774	70771-1774-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
VARENICLINE TARTRATE	82269ASB48	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
VARENICLINE TARTRATE	82269ASB48	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A216723-001	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2023-06-12
A216723-002	VARENICLINE TARTRATE	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB		2023-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216723-001	AB
A216723-002	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.

Product history page 1 of 2 · 46 observed 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	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216723-001	VARENICLINE TARTRATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2023-06-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216723-002	VARENICLINE TARTRATE	EQ 1MG BASE	TABLET / ORAL	AB	2023-06-12	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216723-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216723-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216723-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216723-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216723-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216723-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216723-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216723-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216723-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216723-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216723-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216723-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216723-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216723-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216723-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216723-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216723-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216723-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216723-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216723-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216723-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216723-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216723-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216723-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216723-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216723-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216723-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216723-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216723-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216723-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216723-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216723-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216723-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216723-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216723-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216723-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216723-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216723-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216723-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216723-002	AB	1	`a72a2bbeb626…`

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	Zydus Lifesciences Limited	481b94af-ee34-44be-8ca1-b2415525efac	2023-09-28		Exact identifier ndc (package): 70771-1773-6 ndc (package): 70771-1774-6 ndc (product): 70771-1773 ndc (product): 70771-1774 ndc11 (package): 70771177306 ndc11 (package): 70771177406 spl id: df89bfa8-f749-4840-a207-6499b82516f5 spl set id: 481b94af-ee34-44be-8ca1-b2415525efac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.