Orladeyo
These highlights do not include all the information needed to use ORLADEYO safely and effectively. See full prescribing information for ORLADEYO. ORLADEYO (berotralstat) capsules, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
3527ece1-e7e0-40b1-b0c5-6baeb0deabeb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
BioCryst Pharmaceuticals Inc.
DUNS: 618194609
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Berotralstat hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72769-102
Application NumberNDA214094
Product Classification
M
Marketing Category
C73594
G
Generic Name
Berotralstat hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (5)
Berotralstat hydrochlorideActive
Quantity: 110 mg in 1 1
Code: 88SH1NBL2B
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Berotralstat hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72769-101
Application NumberNDA214094
Product Classification
M
Marketing Category
C73594
G
Generic Name
Berotralstat hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (5)
Berotralstat hydrochlorideActive
Quantity: 150 mg in 1 1
Code: 88SH1NBL2B
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT