FDA.reportPublic FDA data

VARENICLINE

Product NDC
60505-3613
11-digit product format
605053613
Labeler code
60505
Product ID
60505-3613_4fb749d9-409f-d07a-7006-394063557043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARENICLINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp
Application
ANDA201962
Marketing category
ANDA
Marketing start
2023-01-30
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
60505-3613-2VARENICLINE28 in 1 BOTTLETABLET, FILM COATED285
60505-3613-5VARENICLINE56 in 1 BOTTLETABLET, FILM COATED565

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3613-5EA - Each60505-36138fdc679b-22e4-4ebe-b726-8d20ce7658a212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3613VARENICLINE TABLET, FILM COATED VARENICLINE KIT [APOTEX CORP]5Current NDC, 2 package rows20250411_78d1857f-8708-5410-792f-4a3e5e7971a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636671varenicline 0.5 MG Oral TabletPSNe3cc710d-23d8-4d68-b854-b6f5f4e737fc101
636671varenicline 0.5 MG Oral TabletSCDe3cc710d-23d8-4d68-b854-b6f5f4e737fc101
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYe3cc710d-23d8-4d68-b854-b6f5f4e737fc101
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK78d1857f-8708-5410-792f-4a3e5e7971a55
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK78d1857f-8708-5410-792f-4a3e5e7971a55
636671varenicline 0.5 MG Oral TabletPSN78d1857f-8708-5410-792f-4a3e5e7971a55
636676varenicline 1 MG Oral TabletPSN78d1857f-8708-5410-792f-4a3e5e7971a55
749788varenicline 1 MG Oral Tablet 56 Count PackPSN78d1857f-8708-5410-792f-4a3e5e7971a55
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN78d1857f-8708-5410-792f-4a3e5e7971a55
636671varenicline 0.5 MG Oral TabletSCD78d1857f-8708-5410-792f-4a3e5e7971a55
636676varenicline 1 MG Oral TabletSCD78d1857f-8708-5410-792f-4a3e5e7971a55
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY78d1857f-8708-5410-792f-4a3e5e7971a55
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY78d1857f-8708-5410-792f-4a3e5e7971a55
749788varenicline 1 MG Oral Tablet 56 Count PackSY78d1857f-8708-5410-792f-4a3e5e7971a55
749788varenicline continuing months of therapy PackSY78d1857f-8708-5410-792f-4a3e5e7971a55
749289varenicline first month of therapy PackSY78d1857f-8708-5410-792f-4a3e5e7971a55
749289varenicline starting month Pack, 53 Oral TabletsSY78d1857f-8708-5410-792f-4a3e5e7971a55
636671varenicline 0.5 MG Oral TabletPSNfa5a2672-2378-c27f-e053-6294a90aba653
636676varenicline 1 MG Oral TabletPSNfa5a2672-2378-c27f-e053-6294a90aba653
636671varenicline 0.5 MG Oral TabletSCDfa5a2672-2378-c27f-e053-6294a90aba653
636676varenicline 1 MG Oral TabletSCDfa5a2672-2378-c27f-e053-6294a90aba653
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYfa5a2672-2378-c27f-e053-6294a90aba653
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYfa5a2672-2378-c27f-e053-6294a90aba653
636671varenicline 0.5 MG Oral TabletPSN99414eca-c601-431c-8e84-2066b2e8221c1
636671varenicline 0.5 MG Oral TabletSCD99414eca-c601-431c-8e84-2066b2e8221c1
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY99414eca-c601-431c-8e84-2066b2e8221c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-3613-26050536130228 in 1 BOTTLEHistorical
60505-3613-56050536130556 TABLET, FILM COATED in 1 BOTTLE (60505-3613-5) 2023-01-30NoNoHistorical