CHANTIX

Product NDC: 68151-4952
11-digit product format: 681514952
Labeler code: 68151
Product ID: 68151-4952_3770c497-6575-41e9-b795-a60ad5ff2e51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: varenicline tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Carilion Materials Management
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: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f0bb1b01-df09-3a97-b952-a960743e615c	Product name	8	20260223
317a11f5-b985-4a71-b48a-5c9c00753d1c	Product name	1	20220511

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-4952-5	2020-01-31	C162847	48780-1	9d75b9d0-4798-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-4952-5	CHANTIX	1 in 1 PACKAGE	TABLET, FILM COATED	1		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARENICLINE TARTRATE	ACTIVE INGREDIENT	82269ASB48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
VARENICLINE	ACTIVE MOIETY	W6HS99O8ZO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-4952	CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20140820_2468ba8d-4c77-4ea0-88d8-b64497a72222.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82269ASB48	VARENICLINE TARTRATE	375815-87-5	VARENICLINE TARTRATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
637190	CHANTIX 1 MG Oral Tablet	PSN	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
636676	varenicline 1 MG Oral Tablet	PSN	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
637190	varenicline 1 MG Oral Tablet [Chantix]	SBD	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
636676	varenicline 1 MG Oral Tablet	SCD	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
637190	Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
637190	Chantix 1 MG Oral Tablet	SY	2468ba8d-4c77-4ea0-88d8-b64497a72222	2
636676	varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet	SY	2468ba8d-4c77-4ea0-88d8-b64497a72222	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-4952-5	68151495205	1 in 1 PACKAGE	Historical