NDC 72769-102

Orladeyo

Berotralstat Hydrochloride

Orladeyo is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Biocryst Pharmaceuticals Inc.. The primary component is Berotralstat Hydrochloride.

Product ID72769-102_d516947e-2798-445b-bbb6-12184192a9b8
NDC72769-102
Product TypeHuman Prescription Drug
Proprietary NameOrladeyo
Generic NameBerotralstat Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-12-04
Marketing CategoryNDA / NDA
Application NumberNDA214094
Labeler NameBioCryst Pharmaceuticals Inc.
Substance NameBEROTRALSTAT HYDROCHLORIDE
Active Ingredient Strength110 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72769-102-01

4 DOSE PACK in 1 CARTON (72769-102-01) > 1 BLISTER PACK in 1 DOSE PACK > 7 CAPSULE in 1 BLISTER PACK
Marketing Start Date2020-12-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Orladeyo" or generic name "Berotralstat Hydrochloride"

NDCBrand NameGeneric Name
72769-101OrladeyoBerotralstat hydrochloride
72769-102OrladeyoBerotralstat hydrochloride

Trademark Results [Orladeyo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORLADEYO
ORLADEYO
87897816 not registered Live/Pending
BioCryst Pharmaceuticals, Inc.
2018-04-27

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