Home NDC 72769-101 Orladeyo
Product NDC 72769-101
11-digit product format 727690101
Labeler code 72769
Product ID 72769-101_30d087b8-4328-4ec8-bc73-f15bdd7fe7c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Berotralstat hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler BioCryst Pharmaceuticals, Inc.
Application NDA214094
Marketing category NDA
Marketing start 2020-12-04
Substance BEROTRALSTAT HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kallikrein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Orladeyo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEROTRALSTAT HYDROCHLORIDE 150 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 88SH1NBL2B Rxcui 2467565, 2467571, 2467573, 2467575, 2728874, 2728878, 2728880, 2728882, 2728884, 2728886, 2728888, 2728890
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72769-101-01 Orladeyo 4 in 1 CARTON CAPSULE 4 8 72769-101-01 Orladeyo 1 in 1 DOSE PACK CAPSULE 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72769-101 ORLADEYO (BEROTRALSTAT HYDROCHLORIDE) CAPSULE [BIOCRYST PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241102_3527ece1-e7e0-40b1-b0c5-6baeb0deabeb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72769-101-01 72769010101 4 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK 4 dose pack 2020-12-04 0000-00-00 No No Current