FDA.reportPublic FDA data

Varenicline

Product NDC
72603-476
11-digit product format
726030476
Labeler code
72603
Product ID
72603-476_2318a1aa-9c4c-5925-e063-6394a90a5222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA214571
Marketing category
ANDA
Marketing start
2024-09-23
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
72603-476-01Varenicline56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-476-01EA - Each72603-476178a1e47-fbb7-4ef9-8ab1-7c7033297f8e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-476VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [NORTHSTAR RXLLC]1Current NDC, 1 package rows20240928_9031aa0d-2f68-4b9d-903f-ac0e95cbf35f.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) } PackGPCK9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636671varenicline 0.5 MG Oral TabletPSN9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636676varenicline 1 MG Oral TabletPSN9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636671varenicline 0.5 MG Oral TabletSCD9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636676varenicline 1 MG Oral TabletSCD9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
749289varenicline first month of therapy PackSY9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1
749289varenicline starting month Pack, 53 Oral TabletsSY9031aa0d-2f68-4b9d-903f-ac0e95cbf35f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-476-017260304760156 TABLET, FILM COATED in 1 BOTTLE (72603-476-01) 2024-09-23NoNoHistorical