FDA.reportPublic FDA data

Varenicline tartrate

Product NDC
14445-153
11-digit product format
144450153
Labeler code
14445
Product ID
14445-153_97b537d2-8829-42ad-86e9-8523b4430843
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA219106
Marketing category
ANDA
Marketing start
2024-11-01
Substance
VARENICLINE TARTRATE
Active strength
.5 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 tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE.5 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
14445-153-56Varenicline tartrate56 in 1 BOTTLETABLET, FILM COATED563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-153VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [INDOCO REMEDIES LIMITED ]3Current NDC, 1 package rows20241105_cd83bc6c-20f4-42e1-adb4-a3d1d89413f4.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) } PackGPCKcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636671varenicline 0.5 MG Oral TabletPSNcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636676varenicline 1 MG Oral TabletPSNcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636671varenicline 0.5 MG Oral TabletSCDcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636676varenicline 1 MG Oral TabletSCDcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
749289varenicline first month of therapy PackSYcd83bc6c-20f4-42e1-adb4-a3d1d89413f43
749289varenicline starting month Pack, 53 Oral TabletsSYcd83bc6c-20f4-42e1-adb4-a3d1d89413f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
14445-153-561444501535656 TABLET, FILM COATED in 1 BOTTLE (14445-153-56) 2024-11-01NoNoHistorical