FDA.reportPublic FDA data

varenicline

Product NDC
0904-7413
11-digit product format
009047413
Labeler code
0904
Product ID
0904-7413_1297c291-da28-4a73-9c28-d5adee36d7b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA214557
Marketing category
ANDA
Marketing start
2023-12-18
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7413-35varenicline56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7413-35EA - Each0904-7413144983c6-41b7-4afb-8035-4e9b875f52e612024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7413VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [MAJOR PHARMACEUTICALS]1Current NDC, 1 package rows20231223_1297c291-da28-4a73-9c28-d5adee36d7b7.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) } PackGPCK1297c291-da28-4a73-9c28-d5adee36d7b71
636671varenicline 0.5 MG Oral TabletPSN1297c291-da28-4a73-9c28-d5adee36d7b71
636676varenicline 1 MG Oral TabletPSN1297c291-da28-4a73-9c28-d5adee36d7b71
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN1297c291-da28-4a73-9c28-d5adee36d7b71
636671varenicline 0.5 MG Oral TabletSCD1297c291-da28-4a73-9c28-d5adee36d7b71
636676varenicline 1 MG Oral TabletSCD1297c291-da28-4a73-9c28-d5adee36d7b71
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY1297c291-da28-4a73-9c28-d5adee36d7b71
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY1297c291-da28-4a73-9c28-d5adee36d7b71
749289varenicline first month of therapy PackSY1297c291-da28-4a73-9c28-d5adee36d7b71
749289varenicline starting month Pack, 53 Oral TabletsSY1297c291-da28-4a73-9c28-d5adee36d7b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0904-7413-350090474133556 TABLET, FILM COATED in 1 BOTTLE (0904-7413-35) 2023-12-18NoNoHistorical