PRADAXA
These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules for oral use Initial U.S. Approval: 2010
Approved
Approval ID
5db7f199-8752-4d24-85f7-e34ca8f4d02e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dabigatran etexilate mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-899
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2010
FDA Product Classification
INGREDIENTS (20)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
dabigatran etexilate mesylateActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIM
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT