FDA.reportPublic FDA data

VARENICLINE

Product NDC
70748-127
11-digit product format
707480127
Labeler code
70748
Product ID
70748-127_3647a217-0da1-4778-adea-08d19a9c446f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARENICLINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211862
Marketing category
ANDA
Marketing start
2024-01-09
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

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
70748-127-49VARENICLINE56 in 1 BOTTLETABLET, FILM COATED5614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-127VARENICLINE TABLET, FILM COATED VARENICLINE TARTRATE (VARENICLINE TARTRATE ) KIT [LUPIN PHARMACEUTICALS, INC.]8Current NDC, 1 package rows20240405_bf20c4cc-1731-4873-8de1-b93d17591e9f.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) } PackGPCKbf20c4cc-1731-4873-8de1-b93d17591e9f14
636671varenicline 0.5 MG Oral TabletPSNbf20c4cc-1731-4873-8de1-b93d17591e9f14
636676varenicline 1 MG Oral TabletPSNbf20c4cc-1731-4873-8de1-b93d17591e9f14
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNbf20c4cc-1731-4873-8de1-b93d17591e9f14
636671varenicline 0.5 MG Oral TabletSCDbf20c4cc-1731-4873-8de1-b93d17591e9f14
636676varenicline 1 MG Oral TabletSCDbf20c4cc-1731-4873-8de1-b93d17591e9f14
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYbf20c4cc-1731-4873-8de1-b93d17591e9f14
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYbf20c4cc-1731-4873-8de1-b93d17591e9f14
749289varenicline first month of therapy PackSYbf20c4cc-1731-4873-8de1-b93d17591e9f14
749289varenicline starting month Pack, 53 Oral TabletsSYbf20c4cc-1731-4873-8de1-b93d17591e9f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70748-127-497074801274956 TABLET, FILM COATED in 1 BOTTLE (70748-127-49) 2024-01-09YesNoCurrent