Home NDC 82928-300-04 EKTERLY
Product NDC 82928-300
Requested package NDC 82928-300-04
11-digit product format 829280300
Labeler code 82928
Product ID 82928-300_16d31d7e-dc21-4cdb-92b8-56919827a192
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sebetralstat
Dosage form TABLET
Route ORAL
Labeler KalVista Pharmaceuticals Ltd
Application NDA219301
Marketing category NDA
Marketing start 2025-07-03
Substance SEBETRALSTAT
Active strength 300 mg/1
Pharmacologic classes Kallikrein 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219301-001 EKTERLY SEBETRALSTAT 300MG TABLET / ORAL RLD, RS 2025-07-03
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219301-001 NCE 2030-07-03 N219301-001 ODE-534 2032-07-03
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 2026-09-14 22:38:34 2026-08 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219301-001 EKTERLY 300MG TABLET / ORAL RLD, RS 2025-07-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219301-001 10364238 2035-11-26 Drug substance, Drug product 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 10611758 2035-11-26 U-4223 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11001578 2035-11-26 Drug substance, Drug product 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11084809 2035-11-26 U-4223 Drug substance, Drug product 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11198691 2035-11-26 U-4223 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11739068 2037-06-23 U-4223 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11230537 2037-12-25 Drug substance, Drug product 2025-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219301-001 11234939 2039-01-26 U-4223 Drug product 2025-07-29 6a471c1ec25d…
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 EKTERLY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEBETRALSTAT 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O5ZD2TU2B7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717949 Internal RxNorm lookup 2717955 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 82928-300-01 EKTERLY 1 in 1 BLISTER PACK TABLET 1 4 82928-300-02 EKTERLY 2 in 1 BLISTER PACK TABLET 2 4 82928-300-04 EKTERLY 4 in 1 CARTON TABLET 4 4 82928-300-05 EKTERLY 2 in 1 CARTON TABLET 2 4
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82928-300-04 82928030004 4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01) 4 blister pack 2025-07-03 No No Current