Home NDC 72769-112 Orladeyo
Product NDC 72769-112
11-digit product format 727690112
Labeler code 72769
Product ID 72769-112_30d087b8-4328-4ec8-bc73-f15bdd7fe7c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Berotralstat hydrochloride
Dosage form PELLET
Route ORAL
Labeler BioCryst Pharmaceuticals, Inc.
Application NDA219776
Marketing category NDA
Marketing start 2020-12-04
Substance BEROTRALSTAT HYDROCHLORIDE
Active strength 96 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 96 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 72769-112-02 Orladeyo 4 in 1 CARTON PELLET 4 8 72769-112-02 Orladeyo 7 in 1 DOSE PACK PELLET 7 8
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72769-112-02 72769011202 4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKET 4 dose pack 2020-12-12 No No Historical