Pradaxa
These highlights do not include all the information needed to use PRADAXA Oral Pellets safely and effectively. See full prescribing information for PRADAXA Oral Pellets. PRADAXA (dabigatran etexilate) oral pellets Initial U.S. Approval: 2010
Approved
Approval ID
9ac0a64a-8666-45f7-9d4f-40fd894f7e6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0445
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 110 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0440
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 50 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0430
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 30 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0450
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0425
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 20 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
dabigatran etexilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0435
Application NumberNDA214358
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (7)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 40 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT