FDA.reportPublic FDA data

Varenicline tartrate

Product NDC
71921-308
11-digit product format
719210308
Labeler code
71921
Product ID
71921-308_2b9c8b1e-6193-4d8e-9b50-6aca27294263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA219106
Marketing category
ANDA
Marketing start
2024-11-01
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 tartrate
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
71921-308-56Varenicline tartrate56 in 1 BOTTLETABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-308-56EA - Each71921-308d1f3cd65-3776-420d-91e4-7744d5d3575012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-308VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]1Current NDC, 1 package rows20241107_2b9c8b1e-6193-4d8e-9b50-6aca27294263.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) } PackGPCK2b9c8b1e-6193-4d8e-9b50-6aca272942631
636671varenicline 0.5 MG Oral TabletPSN2b9c8b1e-6193-4d8e-9b50-6aca272942631
636676varenicline 1 MG Oral TabletPSN2b9c8b1e-6193-4d8e-9b50-6aca272942631
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN2b9c8b1e-6193-4d8e-9b50-6aca272942631
636671varenicline 0.5 MG Oral TabletSCD2b9c8b1e-6193-4d8e-9b50-6aca272942631
636676varenicline 1 MG Oral TabletSCD2b9c8b1e-6193-4d8e-9b50-6aca272942631
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY2b9c8b1e-6193-4d8e-9b50-6aca272942631
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY2b9c8b1e-6193-4d8e-9b50-6aca272942631
749289varenicline first month of therapy PackSY2b9c8b1e-6193-4d8e-9b50-6aca272942631
749289varenicline starting month Pack, 53 Oral TabletsSY2b9c8b1e-6193-4d8e-9b50-6aca272942631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71921-308-567192103085656 TABLET, FILM COATED in 1 BOTTLE (71921-308-56) 2024-11-01NoNoHistorical