Dabigatran Etexilate
These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN etexilate capsules, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
3c24e235-218b-438e-9456-42c18ff01913
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dabigatran Etexilate
PRODUCT DETAILS
NDC Product Code31722-622
Application NumberANDA207961
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 8, 2023
Generic NameDabigatran Etexilate
INGREDIENTS (15)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Dabigatran Etexilate
PRODUCT DETAILS
NDC Product Code31722-621
Application NumberANDA207961
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 8, 2023
Generic NameDabigatran Etexilate
INGREDIENTS (15)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 75 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT