NDC Code(s) : 67877-475-60, 67877-474-60
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dabigatran Etexilate Dabigatran Etexilate CAPSULE, COATED PELLETS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-475
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABIGATRAN ETEXILATE MESYLATE(UNII: SC7NUW5IIT)
(DABIGATRAN - UNII:I0VM4M70GC) 		DABIGATRAN150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POVIDONE K25(UNII: K0KQV10C35)
TALC(UNII: 7SEV7J4R1U)
TARTARIC ACID(UNII: W4888I119H)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
POLYETHYLENE GLYCOL 600(UNII: NL4J9F21N9)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color BLUE (Light navy blue opaque), WHITE (Light cream opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code DAB;150
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-475-6060 in 1 BOTTLE Type 0: Not a Combination Product20/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208040 06/20/2022
Dabigatran Etexilate Dabigatran Etexilate CAPSULE, COATED PELLETS
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-474
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABIGATRAN ETEXILATE MESYLATE(UNII: SC7NUW5IIT)
(DABIGATRAN - UNII:I0VM4M70GC) 		DABIGATRAN75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POVIDONE K25(UNII: K0KQV10C35)
TALC(UNII: 7SEV7J4R1U)
TARTARIC ACID(UNII: W4888I119H)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
POLYETHYLENE GLYCOL 600(UNII: NL4J9F21N9)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
AMMONIA(UNII: 5138Q19F1X)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color WHITE (Light cream opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code DAB;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-474-6060 in 1 BOTTLE Type 0: Not a Combination Product20/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208040 06/20/2022

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-474, 67877-475)

PRINCIPAL DISPLAY PANEL


NDC 67877-474-60


Dabigatran Etexilate Capsules 75 mg
Rx Only 60 Capsules.
dab-igatran-75-mg
NDC 67877-475-60


Dabigatran Etexilate capsules 150 mg
Rx Only 60 Capsules.

dab-igatran-75-mg