FDA.reportPublic FDA data

varenicline tartrate

Product NDC
68462-894
11-digit product format
684620894
Labeler code
68462
Product ID
68462-894_67a82933-5f10-4a9a-8605-d09cd2f08d52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA214255
Marketing category
ANDA
Marketing start
2023-08-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
varenicline tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 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
68462-894-04varenicline tartrate56 in 1 BLISTER PACKTABLET, FILM COATED568
68462-894-04varenicline tartrate1 in 1 CARTONTABLET, FILM COATED18
68462-894-56varenicline tartrate56 in 1 BOTTLETABLET, FILM COATED568

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-894-04EA - Each68462-8947be8da9d-fa08-44e2-ac73-c86f5141f78a12024-06-10
68462-894-56EA - Each68462-894e39db4a9-2fab-420f-b717-aaed4125f39a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-894VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE (VARENICLINE TARTRATE) KIT [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, 3 package rows20230826_e8a06e8e-1938-412c-a98a-28f0a29fe3ac.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) } PackGPCKe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636671varenicline 0.5 MG Oral TabletPSNe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636676varenicline 1 MG Oral TabletPSNe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749788varenicline 1 MG Oral Tablet 56 Count PackPSNe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636671varenicline 0.5 MG Oral TabletSCDe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636676varenicline 1 MG Oral TabletSCDe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749788varenicline 1 MG Oral Tablet 56 Count PackSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749788varenicline continuing months of therapy PackSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749289varenicline first month of therapy PackSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8
749289varenicline starting month Pack, 53 Oral TabletsSYe8a06e8e-1938-412c-a98a-28f0a29fe3ac8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-894-04684620894041 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-08-22NoNoCurrent
68462-894-566846208945656 TABLET, FILM COATED in 1 BOTTLE (68462-894-56) 2023-08-22NoNoCurrent