Home NDC 72769-111 Orladeyo
Product NDC 72769-111
11-digit product format 727690111
Labeler code 72769
Product ID 72769-111_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 72 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219776-001 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-002 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-003 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 N219776-004 ORLADEYO BEROTRALSTAT DIHYDROCHLORIDE EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11
Orange Book patents# Current patent rows page 1 of 2 · 128 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-001 10329260*PED 2035-09-09 Pediatric extension N219776-001 10689346*PED 2035-09-09 Pediatric extension N219776-001 11230530*PED 2035-09-09 Pediatric extension N219776-001 11708333*PED 2035-09-09 Pediatric extension N219776-001 12116346*PED 2035-09-09 Pediatric extension N219776-001 10125102*PED 2035-10-07 Pediatric extension N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-001 10662160*PED 2040-05-01 Pediatric extension N219776-001 11117867*PED 2040-05-01 Pediatric extension N219776-001 11618733*PED 2040-05-01 Pediatric extension N219776-001 12344585*PED 2040-05-01 Pediatric extension N219776-001 12545645*PED 2040-05-01 Pediatric extension N219776-001 12545646*PED 2040-05-01 Pediatric extension N219776-001 12545647*PED 2040-05-01 Pediatric extension N219776-001 12552750*PED 2040-05-01 Pediatric extension N219776-001 12590068*PED 2040-05-01 Pediatric extension N219776-001 12590069*PED 2040-05-01 Pediatric extension N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-002 10329260*PED 2035-09-09 Pediatric extension N219776-002 10689346*PED 2035-09-09 Pediatric extension N219776-002 11230530*PED 2035-09-09 Pediatric extension N219776-002 11708333*PED 2035-09-09 Pediatric extension N219776-002 12116346*PED 2035-09-09 Pediatric extension N219776-002 10125102*PED 2035-10-07 Pediatric extension N219776-002 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-002 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-002 11618733 2039-11-01 U-4535 2026-06-10 N219776-002 12344585 2039-11-01 U-4535 2026-06-10 N219776-002 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 N219776-002 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-002 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 N219776-002 10662160*PED 2040-05-01 Pediatric extension N219776-002 11117867*PED 2040-05-01 Pediatric extension N219776-002 11618733*PED 2040-05-01 Pediatric extension N219776-002 12344585*PED 2040-05-01 Pediatric extension N219776-002 12545645*PED 2040-05-01 Pediatric extension N219776-002 12545646*PED 2040-05-01 Pediatric extension N219776-002 12545647*PED 2040-05-01 Pediatric extension N219776-002 12552750*PED 2040-05-01 Pediatric extension N219776-002 12590068*PED 2040-05-01 Pediatric extension N219776-002 12590069*PED 2040-05-01 Pediatric extension N219776-003 10329260 2035-03-09 Drug substance 2026-06-10 N219776-003 10689346 2035-03-09 U-4535 2026-06-10 N219776-003 11230530 2035-03-09 U-4535 2026-06-10 N219776-003 11708333 2035-03-09 U-4535 2026-06-10 N219776-003 12116346 2035-03-09 Drug substance 2026-06-10 N219776-003 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 N219776-003 10329260*PED 2035-09-09 Pediatric extension N219776-003 10689346*PED 2035-09-09 Pediatric extension N219776-003 11230530*PED 2035-09-09 Pediatric extension N219776-003 11708333*PED 2035-09-09 Pediatric extension N219776-003 12116346*PED 2035-09-09 Pediatric extension N219776-003 10125102*PED 2035-10-07 Pediatric extension N219776-003 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 N219776-003 11117867 2039-11-01 U-4535 Drug product 2026-06-10 N219776-003 11618733 2039-11-01 U-4535 2026-06-10 N219776-003 12344585 2039-11-01 U-4535 2026-06-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 128 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10329260*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10689346*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11230530*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11708333*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12116346*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10125102*PED 2035-10-07 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 10662160*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11117867*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 11618733*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12344585*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545645*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545646*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12545647*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12552750*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590068*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-001 12590069*PED 2040-05-01 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10329260*PED 2035-09-09 Pediatric extension a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219776-002 10689346*PED 2035-09-09 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Orladeyo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEROTRALSTAT HYDROCHLORIDE 72 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88SH1NBL2B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2467565 Internal RxNorm lookup 2467571 Internal RxNorm lookup 2467573 Internal RxNorm lookup 2467575 Internal RxNorm lookup 2728874 Internal RxNorm lookup 2728878 Internal RxNorm lookup 2728880 Internal RxNorm lookup 2728882 Internal RxNorm lookup 2728884 Internal RxNorm lookup 2728886 Internal RxNorm lookup 2728888 Internal RxNorm lookup 2728890 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72769-111-02 Orladeyo 7 in 1 DOSE PACK PELLET 7 8 72769-111-02 Orladeyo 4 in 1 CARTON PELLET 4 8
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orladeyo BEROTRALSTAT HYDROCHLORIDE BioCryst Pharmaceuticals, Inc. 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb 2026-02-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 219776 application number: NDA219776 ndc (product): 72769-111
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72769-111-02 72769011102 4 DOSE PACK in 1 CARTON (72769-111-02) / 7 PACKET in 1 DOSE PACK / 12 PELLET in 1 PACKET 4 dose pack 2020-12-12 No No Current