FDA.reportPublic FDA data

CHANTIX

Product NDC
63187-618
11-digit product format
631870618
Labeler code
63187
Product ID
63187-618_1da9a839-db61-41e9-a214-d007b8f59820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
KIT
Labeler
Proficient Rx LP
Application
NDA021928
Marketing category
NDA
Marketing start
2006-05-10
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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui636671, 636676, 637188, 637190, 749289, 795737

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
63187-618-53CHANTIX1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-618CHANTIX (VARENICLINE TARTRATE) KIT [PROFICIENT RX LP]4Current NDC, Legacy NDC, 1 package rows20200218_0fefd790-b526-4f2f-8c83-5f39f7306556.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
795737{11 (varenicline 0.5 MG Oral Tablet [Chantix]) / 42 (varenicline 1 MG Oral Tablet [Chantix]) } Pack [Chantix First Month of Therapy]BPCK0fefd790-b526-4f2f-8c83-5f39f73065564
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCK0fefd790-b526-4f2f-8c83-5f39f73065564
637188CHANTIX 0.5 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
637190CHANTIX 1 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix Starting Month PackPSN0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG Oral TabletPSN0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSN0fefd790-b526-4f2f-8c83-5f39f73065564
637188varenicline 0.5 MG Oral Tablet [Chantix]SBD0fefd790-b526-4f2f-8c83-5f39f73065564
637190varenicline 1 MG Oral Tablet [Chantix]SBD0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG Oral TabletSCD0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG Oral TabletSCD0fefd790-b526-4f2f-8c83-5f39f73065564
637188Chantix 0.5 MG Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
637190Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
637190Chantix 1 MG Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix First Month of Therapy PackSY0fefd790-b526-4f2f-8c83-5f39f73065564
795737Chantix Starting Month PAKSY0fefd790-b526-4f2f-8c83-5f39f73065564
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSY0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline first month of therapy PackSY0fefd790-b526-4f2f-8c83-5f39f73065564
749289varenicline starting month Pack, 53 Oral TabletsSY0fefd790-b526-4f2f-8c83-5f39f73065564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-618-53631870618531 KIT in 1 CARTON (63187-618-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK1 kit2018-12-010000-00-00NoNoCurrent