FDA.reportPublic FDA data

CHANTIX

Product NDC
71205-381
11-digit product format
712050381
Labeler code
71205
Product ID
71205-381_f22e3aef-714b-4014-8d77-83ee03fd1f57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHANTIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636676, 637190, 749788, 795735

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
71205-381-56CHANTIX1 in 1 CARTONTABLET, FILM COATED11
71205-381-56CHANTIX56 in 1 BLISTER PACKTABLET, FILM COATED561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-381-56EA - Each71205-381bd058a6e-3234-47ce-ade7-11b01618769712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-381CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20200121_f22e3aef-714b-4014-8d77-83ee03fd1f57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
795735{56 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix Continuing Months Of Therapy]BPCKf22e3aef-714b-4014-8d77-83ee03fd1f571
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKf22e3aef-714b-4014-8d77-83ee03fd1f571
637190CHANTIX 1 MG Oral TabletPSNf22e3aef-714b-4014-8d77-83ee03fd1f571
795735Chantix Continuing Month Pack 1 MG 56 CountPSNf22e3aef-714b-4014-8d77-83ee03fd1f571
636676varenicline 1 MG Oral TabletPSNf22e3aef-714b-4014-8d77-83ee03fd1f571
749788varenicline 1 MG Oral Tablet 56 Count PackPSNf22e3aef-714b-4014-8d77-83ee03fd1f571
637190varenicline 1 MG Oral Tablet [Chantix]SBDf22e3aef-714b-4014-8d77-83ee03fd1f571
636676varenicline 1 MG Oral TabletSCDf22e3aef-714b-4014-8d77-83ee03fd1f571
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf22e3aef-714b-4014-8d77-83ee03fd1f571
637190Chantix 1 MG Oral TabletSYf22e3aef-714b-4014-8d77-83ee03fd1f571
795735Chantix 1 MG Tablet Continuing Months Of Therapy PackSYf22e3aef-714b-4014-8d77-83ee03fd1f571
795735Chantix Continuing Months Of Therapy 1 MG PackSYf22e3aef-714b-4014-8d77-83ee03fd1f571
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYf22e3aef-714b-4014-8d77-83ee03fd1f571
749788varenicline 1 MG Oral Tablet 56 Count PackSYf22e3aef-714b-4014-8d77-83ee03fd1f571
749788varenicline continuing months of therapy PackSYf22e3aef-714b-4014-8d77-83ee03fd1f571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-381-56712050381561 BLISTER PACK in 1 CARTON (71205-381-56) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-01-090000-00-00NoNoCurrent