FDA.reportPublic FDA data

Varenicline

Product NDC
59651-418
11-digit product format
596510418
Labeler code
59651
Product ID
59651-418_0004a0bb-87c0-46f8-b36a-95c98107395d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214595
Marketing category
ANDA
Marketing start
2025-05-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varenicline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 749289

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-418-55Varenicline1 in 1 CARTONTABLET, FILM COATED11
59651-418-55Varenicline56 in 1 BLISTER PACKTABLET, FILM COATED561
59651-418-56Varenicline56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-418-56EA - Each59651-418c5ffa2b6-87fd-4289-af1d-00c7236517f012026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-418VARENICLINE TABLET, FILM COATED VARENICLINE KIT [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20250510_0004a0bb-87c0-46f8-b36a-95c98107395d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK0004a0bb-87c0-46f8-b36a-95c98107395d1
636671varenicline 0.5 MG Oral TabletPSN0004a0bb-87c0-46f8-b36a-95c98107395d1
636676varenicline 1 MG Oral TabletPSN0004a0bb-87c0-46f8-b36a-95c98107395d1
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN0004a0bb-87c0-46f8-b36a-95c98107395d1
636671varenicline 0.5 MG Oral TabletSCD0004a0bb-87c0-46f8-b36a-95c98107395d1
636676varenicline 1 MG Oral TabletSCD0004a0bb-87c0-46f8-b36a-95c98107395d1
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY0004a0bb-87c0-46f8-b36a-95c98107395d1
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0004a0bb-87c0-46f8-b36a-95c98107395d1
749289varenicline first month of therapy PackSY0004a0bb-87c0-46f8-b36a-95c98107395d1
749289varenicline starting month Pack, 53 Oral TabletsSY0004a0bb-87c0-46f8-b36a-95c98107395d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-418-55596510418551 BLISTER PACK in 1 CARTON (59651-418-55) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-05-02NoNoCurrent
59651-418-565965104185656 TABLET, FILM COATED in 1 BOTTLE (59651-418-56) 2025-05-02NoNoCurrent