NDC Code(s) : 68462-386-30, 68462-386-90, 68462-386-14, 68462-387-30, 68462-387-90, 68462-387-14
Packager : Glenmark Pharmaceuticals Inc., USA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

solifenacin succinatesolifenacin succinate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-386
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIFENACIN SUCCINATE(UNII: KKA5DLD701)
(SOLIFENACIN - UNII:A8910SQJ1U) 		SOLIFENACIN SUCCINATE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 6 mm
Flavor Imprint Code G;51
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-386-3030 in 1 BOTTLE Type 0: Not a Combination Product20/05/2019
2NDC:68462-386-9090 in 1 BOTTLE Type 0: Not a Combination Product20/05/2019
3NDC:68462-386-1410 in 1 CARTON 20/05/2019
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209239 05/20/2019
solifenacin succinatesolifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-387
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOLIFENACIN SUCCINATE(UNII: KKA5DLD701)
(SOLIFENACIN - UNII:A8910SQJ1U) 		SOLIFENACIN SUCCINATE10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 8 mm
Flavor Imprint Code G;52
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-387-3030 in 1 BOTTLE Type 0: Not a Combination Product20/05/2019
2NDC:68462-387-9090 in 1 BOTTLE Type 0: Not a Combination Product20/05/2019
3NDC:68462-387-1410 in 1 CARTON 20/05/2019
310 in 1 BLISTER PACK Type 0: Not a Combination Product20/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209239 05/20/2019

LABELER - Glenmark Pharmaceuticals Inc., USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 862603186 MANUFACTURE(68462-386, 68462-387), ANALYSIS(68462-386, 68462-387)

PRINCIPAL DISPLAY PANEL

NDC 68462-386-30

Solifenacin Succinate Tablets, 5 mg

30 Tablets-Bottle

LBL5mg30.jpg

PRINCIPAL DISPLAY PANEL

NDC 68462-387-30

Solifenacin Succinate Tablets, 10 mg

30 Tablets-Bottle

LBL10mg30.jpg