NDC Code(s) : 67877-743-95, 67877-744-95, 67877-744-54, 67877-745-54
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

varenicline varenicline tartrate TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-743
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARENICLINE TARTRATE(UNII: 82269ASB48)
(VARENICLINE - UNII:W6HS99O8ZO) 		VARENICLINE0.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsular) Size 8 mm
Flavor Imprint Code VC;0;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-743-9556 in 1 BOTTLE Type 0: Not a Combination Product25/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214557 08/25/2023
varenicline varenicline tartrate TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-744
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARENICLINE TARTRATE(UNII: 82269ASB48)
(VARENICLINE - UNII:W6HS99O8ZO) 		VARENICLINE1 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color BLUE (LIGHT BLUE) Score no score
Shape OVAL (Capsular) Size 10 mm
Flavor Imprint Code VC;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-744-9556 in 1 BOTTLE Type 0: Not a Combination Product25/08/2023
2NDC:67877-744-541 in 1 CARTON 25/08/2023
256 in 1 BLISTER PACK Type 0: Not a Combination Product25/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214557 08/25/2023
VareniclineVarenicline tartrate KIT
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-745
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TRIACETIN(UNII: XHX3C3X673)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
STEARIC ACID(UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TRIACETIN(UNII: XHX3C3X673)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
STEARIC ACID(UNII: 4ELV7Z65AP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-745-541 in 1 CARTON Type 0: Not a Combination Product25/08/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214557 08/25/2023

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 677605851 ANALYSIS(67877-743, 67877-744, 67877-745), MANUFACTURE(67877-743, 67877-744, 67877-745), PACK(67877-743, 67877-744, 67877-745)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL- STARTING MONTH BOX- BLISTER CARD
NDC 67877-745-54
Rx Only
Varenicline Tablets
STARTING MONTH BOX (Your first 4 weeks)


var051-1a

PRINCIPAL DISPLAY PANEL- STARTING MONTH BOX- CARTON
NDC 67877-745-54
Rx Only
Varenicline Tablets
STARTING MONTH BOX (Your first 4 weeks)


var051-1a

PRINCIPAL DISPLAY PANEL- CONTINUING MONTH BOX- BLISTER CARD
NDC 67877-744-54
Rx Only
Varenicline Tablets
CONTINUING PACK 
 

var051-1a

PRINCIPAL DISPLAY PANEL- CONTINUING MONTH BOX- CARTON
NDC 67877-744-54
Rx Only
Varenicline Tablets
CONTINUING MONTH BOX (Your next 4 weeks)



var051-1a

PRINCIPAL DISPLAY PANEL- 0.5 MG BOTTLE PACK OF 56 TABLETS
NDC 67877-743-95
Varenicline Tablets


var051-1a

PRINCIPAL DISPLAY PANEL- 1 MG BOTTLE PACK OF 56 TABLETS
NDC 67877-744-95
Varenicline Tablets 


var051-1a