NDC 31722-621

Dabigatran Etexilate

Dabigatran Etexilate

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

Product ID31722-621_dc10c066-1b7d-8d51-e053-2a95a90ad4aa
NDC31722-621
Product TypeHuman Prescription Drug
Proprietary NameDabigatran Etexilate
Generic NameDabigatran Etexilate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-05-06
Marketing CategoryANDA /
Application NumberANDA207961
Labeler NameCamber Pharmaceuticals, Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Active Ingredient Strength75 mg/1
Pharm ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 31722-621-60

60 CAPSULE in 1 BOTTLE (31722-621-60)
Marketing Start Date2020-05-06
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
31722-621Dabigatran EtexilateDabigatran Etexilate
31722-622Dabigatran EtexilateDabigatran Etexilate
67877-474Dabigatran EtexilateDabigatran Etexilate
67877-475Dabigatran EtexilateDabigatran Etexilate
0597-0425Pradaxadabigatran etexilate
0597-0430Pradaxadabigatran etexilate
0597-0435Pradaxadabigatran etexilate
0597-0440Pradaxadabigatran etexilate
0597-0445Pradaxadabigatran etexilate
0597-0450Pradaxadabigatran etexilate

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