NDC 0597-0440

Pradaxa

Dabigatran Etexilate Mesylate

Pradaxa is a Oral Pellet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Dabigatran Etexilate Mesylate.

• Product ID: 0597-0440_435b5f18-05cd-4a0b-9627-5aec67b79974
• NDC: 0597-0440
• Product Type: Human Prescription Drug
• Proprietary Name: Pradaxa
• Generic Name: Dabigatran Etexilate Mesylate
• Dosage Form: Pellet
• Route of Administration: ORAL
• Marketing Start Date: 2022-02-01
• Marketing Category: NDA /
• Application Number: NDA214358
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: DABIGATRAN ETEXILATE MESYLATE
• Active Ingredient Strength: 50 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0597-0440-53

1 BAG in 1 CARTON (0597-0440-53) > 60 PELLET in 1 BAG

• Marketing Start Date: 2022-02-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Pradaxa" or generic name "Dabigatran Etexilate Mesylate"

NDC	Brand Name	Generic Name
0597-0108	Pradaxa	dabigatran etexilate mesylate
0597-0135	Pradaxa	dabigatran etexilate mesylate
0597-0149	Pradaxa	dabigatran etexilate mesylate
0597-0355	Pradaxa	dabigatran etexilate mesylate
0597-0360	Pradaxa	dabigatran etexilate mesylate
0597-0425	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
0597-0430	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
0597-0435	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
0597-0440	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
0597-0445	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
0597-0450	Pradaxa	DABIGATRAN ETEXILATE MESYLATE
21695-899	PRADAXA	dabigatran etexilate mesylate
50090-3617	Pradaxa	dabigatran etexilate mesylate
50090-4480	Pradaxa	dabigatran etexilate mesylate
63629-8242	Pradaxa	Pradaxa