FDA.reportPublic FDA data

VARENICLINE TARTRATE

Product NDC
85742-016
11-digit product format
857420016
Labeler code
85742
Product ID
85742-016_bfc03c5c-16ca-4b83-af77-a9c539b87813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARENICLINE TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kanchan Healthcare Inc
Application
ANDA217151
Marketing category
ANDA
Marketing start
2023-10-01
Substance
VARENICLINE TARTRATE
Active strength
1 mg/561
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/561

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
85742-016-15VARENICLINE TARTRATE56 in 1 BOTTLETABLET, FILM COATED561
85742-016-16VARENICLINE TARTRATE1 in 1 BOXTABLET, FILM COATED11
85742-016-16VARENICLINE TARTRATE56 in 1 BLISTER PACKTABLET, FILM COATED561

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) } PackGPCK1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636671varenicline 0.5 MG Oral TabletPSN1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636676varenicline 1 MG Oral TabletPSN1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749788varenicline 1 MG Oral Tablet 56 Count PackPSN1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636671varenicline 0.5 MG Oral TabletSCD1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636676varenicline 1 MG Oral TabletSCD1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749788varenicline 1 MG Oral Tablet 56 Count PackSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749788varenicline continuing months of therapy PackSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749289varenicline first month of therapy PackSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51
749289varenicline starting month Pack, 53 Oral TabletsSY1624125c-a0c7-49ee-be00-9bfae4ff9bf51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85742-016-158574200161556 TABLET, FILM COATED in 1 BOTTLE (85742-016-15) 2023-10-01NoNoCurrent
85742-016-16857420016161 BLISTER PACK in 1 BOX (85742-016-16) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-10-01NoNoCurrent