Home NDC 72769-111 Orladeyo
Product NDC 72769-111
11-digit product format 727690111
Labeler code 72769
Product ID 72769-111_0d739120-e251-49bc-ad25-10f587ac45e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Berotralstat hydrochloride
Dosage form PELLET
Route ORAL
Labeler BioCryst Pharmaceuticals Inc.
Application NDA219776
Marketing category NDA
Marketing start 2025-12-12
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 44 .
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 2026-10-15 13:18:30 2026-09 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219776-001 ORLADEYO EQ 72MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-002 ORLADEYO EQ 96MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-003 ORLADEYO EQ 108MG BASE/PACKET PELLETS / ORAL RLD 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219776-004 ORLADEYO EQ 132MG BASE/PACKET PELLETS / ORAL RLD, RS 2025-12-11 caaa826d4ba7…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 13 · 512 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N219776-001 10329260 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10689346 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11230530 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11708333 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12116346 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11230530*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11708333*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12116346*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10125102*PED 2035-10-07 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10662160 2039-11-01 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11117867 2039-11-01 U-4535 Drug product 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11618733 2039-11-01 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12344585 2039-11-01 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545645 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545646 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545647 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12552750 2039-11-01 Drug substance, Drug product 2026-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590068 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590069 2039-11-01 Drug substance, Drug product 2026-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 10662160*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11117867*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 11618733*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12344585*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545645*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545646*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12545647*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12552750*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590068*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-001 12590069*PED 2040-05-01 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10329260 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10689346 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 11230530 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 11708333 2035-03-09 U-4535 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 12116346 2035-03-09 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10125102 2035-04-07 U-4535 Drug substance 2026-06-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10329260*PED 2035-09-09 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N219776-002 10689346*PED 2035-09-09 Pediatric extension c2088c7a36db…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 14 matching rows.
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
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 2025-12-12 No No Current