FDA.reportPublic FDA data

Varenicline

Product NDC
27241-173
11-digit product format
272410173
Labeler code
27241
Product ID
27241-173_1c32f27d-6637-481f-9df9-9ef064fd86e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213019
Marketing category
ANDA
Marketing start
2024-01-31
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
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, 749788

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
27241-173-56Varenicline56 in 1 BOTTLETABLET, FILM COATED566

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-173-56EA - Each27241-173a83816fb-9885-440f-95e5-d33b664e5cae12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-173VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [AJANTA PHARMA USA INC.]5Current NDC, 1 package rows20240322_2f86bb7b-c6a6-4915-8ba1-17251540971c.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) } PackGPCK2f86bb7b-c6a6-4915-8ba1-17251540971c6
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK2f86bb7b-c6a6-4915-8ba1-17251540971c6
636671varenicline 0.5 MG Oral TabletPSN2f86bb7b-c6a6-4915-8ba1-17251540971c6
636676varenicline 1 MG Oral TabletPSN2f86bb7b-c6a6-4915-8ba1-17251540971c6
749788varenicline 1 MG Oral Tablet 56 Count PackPSN2f86bb7b-c6a6-4915-8ba1-17251540971c6
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN2f86bb7b-c6a6-4915-8ba1-17251540971c6
636671varenicline 0.5 MG Oral TabletSCD2f86bb7b-c6a6-4915-8ba1-17251540971c6
636676varenicline 1 MG Oral TabletSCD2f86bb7b-c6a6-4915-8ba1-17251540971c6
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY2f86bb7b-c6a6-4915-8ba1-17251540971c6
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY2f86bb7b-c6a6-4915-8ba1-17251540971c6
749788varenicline 1 MG Oral Tablet 56 Count PackSY2f86bb7b-c6a6-4915-8ba1-17251540971c6
749788varenicline continuing months of therapy PackSY2f86bb7b-c6a6-4915-8ba1-17251540971c6
749289varenicline first month of therapy PackSY2f86bb7b-c6a6-4915-8ba1-17251540971c6
749289varenicline starting month Pack, 53 Oral TabletsSY2f86bb7b-c6a6-4915-8ba1-17251540971c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-173-562724101735656 TABLET, FILM COATED in 1 BOTTLE (27241-173-56) 2024-01-31NoNoHistorical