FDA.reportPublic FDA data

CHANTIX

Product NDC
50090-4481
11-digit product format
500904481
Labeler code
50090
Product ID
50090-4481_c604c017-10cb-4d16-8de3-27494cdd70df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
Marketing end
0000-00-00
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4481-02023-01-30C16284748780-1f386c649-df12-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4481-0CHANTIX56 in 1 BOTTLETABLET, FILM COATED563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4481CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210417_9a0d0273-8099-420a-b4e1-097153a4aecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637188CHANTIX 0.5 MG Oral TabletPSN9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG Oral TabletPSN9a0d0273-8099-420a-b4e1-097153a4aecb3
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG Oral TabletSCD9a0d0273-8099-420a-b4e1-097153a4aecb3
637188Chantix 0.5 MG Oral TabletSY9a0d0273-8099-420a-b4e1-097153a4aecb3
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY9a0d0273-8099-420a-b4e1-097153a4aecb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4481-05009044810056 TABLET, FILM COATED in 1 BOTTLE (50090-4481-0) 2019-08-280000-00-00NoNoCurrent