FDA.reportPublic FDA data

varenicline tartrate

Product NDC
43598-908
11-digit product format
435980908
Labeler code
43598
Product ID
43598-908_65233c50-9a25-15c3-cc2b-98713a8173b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc.
Application
ANDA215931
Marketing category
ANDA
Marketing start
2024-12-13
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
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 TARTRATE1 mg/1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-908-56varenicline tartrate56 in 1 BOTTLETABLET, FILM COATED566

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-908-56EA - Each43598-908f7ee817f-a59e-4b76-8f72-a966817da88712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-908VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE KIT [DR. REDDYS LABORATORIES INC.]6Current NDC, 1 package rows20250427_16ee0a83-88d7-97de-1e07-f9e6dcb5c934.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) } PackGPCK16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCK16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636671varenicline 0.5 MG Oral TabletPSN16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636676varenicline 1 MG Oral TabletPSN16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749788varenicline 1 MG Oral Tablet 56 Count PackPSN16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636671varenicline 0.5 MG Oral TabletSCD16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636676varenicline 1 MG Oral TabletSCD16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749788varenicline 1 MG Oral Tablet 56 Count PackSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749788varenicline continuing months of therapy PackSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749289varenicline first month of therapy PackSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346
749289varenicline starting month Pack, 53 Oral TabletsSY16ee0a83-88d7-97de-1e07-f9e6dcb5c9346

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-908-564359809085656 TABLET, FILM COATED in 1 BOTTLE (43598-908-56) 2024-12-13NoNoCurrent