MedPath

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Pradaxa - FDA Drug Approval Details