NDC 72769-101

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 ID: 72769-101_d516947e-2798-445b-bbb6-12184192a9b8
• NDC: 72769-101
• Product Type: Human Prescription Drug
• Proprietary Name: Orladeyo
• Generic Name: Berotralstat Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2020-12-04
• Marketing Category: NDA / NDA
• Application Number: NDA214094
• Labeler Name: BioCryst Pharmaceuticals Inc.
• Substance Name: BEROTRALSTAT HYDROCHLORIDE
• Active Ingredient Strength: 150 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 72769-101-01

4 DOSE PACK in 1 CARTON (72769-101-01) > 1 BLISTER PACK in 1 DOSE PACK > 7 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2020-12-04
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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

NDC	Brand Name	Generic Name
72769-101	Orladeyo	Berotralstat hydrochloride
72769-102	Orladeyo	Berotralstat hydrochloride