FDA.reportPublic FDA data

Varenicline

Product NDC
0378-5090
11-digit product format
003785090
Labeler code
0378
Product ID
0378-5090_5b7b6e3b-f427-4000-b252-968f3adbaa3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Varenicline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202019
Marketing category
ANDA
Marketing start
2024-03-14
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Varenicline

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-5090-73Varenicline56 in 1 BOTTLE, PLASTICTABLET, FILM COATED563

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5090-73EA - Each0378-5090a5cac72c-498b-41a3-a451-564874d78e0912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5090VARENICLINE TABLET, FILM COATED VARENICLINE KIT [MYLAN PHARMACEUTICALS INC.]3Current NDC, 1 package rows20250501_4233fb78-ac6c-49f3-aad8-7e4bee18cac6.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) } PackGPCK4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636671varenicline 0.5 MG Oral TabletPSN4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636676varenicline 1 MG Oral TabletPSN4233fb78-ac6c-49f3-aad8-7e4bee18cac63
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636671varenicline 0.5 MG Oral TabletSCD4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636676varenicline 1 MG Oral TabletSCD4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY4233fb78-ac6c-49f3-aad8-7e4bee18cac63
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY4233fb78-ac6c-49f3-aad8-7e4bee18cac63
749289varenicline first month of therapy PackSY4233fb78-ac6c-49f3-aad8-7e4bee18cac63
749289varenicline starting month Pack, 53 Oral TabletsSY4233fb78-ac6c-49f3-aad8-7e4bee18cac63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-5090-730037850907356 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5090-73) 2024-03-142026-07-31NoNoHistorical