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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219301-001EKTERLYSEBETRALSTAT300MGTABLET / ORALRLD, RS2025-07-03

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219301-001103642382035-11-26Drug substance, Drug product2025-07-29
N219301-001106117582035-11-26U-42232025-07-29
N219301-001110015782035-11-26Drug substance, Drug product2025-07-29
N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-29
N219301-001111986912035-11-26U-42232025-07-29
N219301-001117390682037-06-23U-42232025-07-29
N219301-001112305372037-12-25Drug substance, Drug product2025-07-29
N219301-001112349392039-01-26U-4223Drug product2025-07-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219301-001NCE2030-07-03
N219301-001ODE-5342032-07-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-0384e616aacf4f…
2026-08-18 06:07:402026-07N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219301-001EKTERLY300MGTABLET / ORALRLD, RS2025-07-03a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219301-001103642382035-11-26Drug substance, Drug product2025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001106117582035-11-26U-42232025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001110015782035-11-26Drug substance, Drug product2025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001111986912035-11-26U-42232025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001117390682037-06-23U-42232025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001112305372037-12-25Drug substance, Drug product2025-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N219301-001112349392039-01-26U-4223Drug product2025-07-2984e616aacf4f…
2026-08-18 06:07:402026-07N219301-001103642382035-11-26Drug substance, Drug product2025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001106117582035-11-26U-42232025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001110015782035-11-26Drug substance, Drug product2025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001111986912035-11-26U-42232025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001117390682037-06-23U-42232025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001112305372037-12-25Drug substance, Drug product2025-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001112349392039-01-26U-4223Drug product2025-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219301-001103642382035-11-26Drug substance, Drug product2025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001106117582035-11-26U-42232025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001110015782035-11-26Drug substance, Drug product2025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001111986912035-11-26U-42232025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001117390682037-06-23U-42232025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001112305372037-12-25Drug substance, Drug product2025-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219301-001112349392039-01-26U-4223Drug product2025-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001103642382035-11-26Drug substance, Drug product2025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001106117582035-11-26U-42232025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001110015782035-11-26Drug substance, Drug product2025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001111986912035-11-26U-42232025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001117390682037-06-23U-42232025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001112305372037-12-25Drug substance, Drug product2025-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001112349392039-01-26U-4223Drug product2025-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N219301-001103642382035-11-26Drug substance, Drug product2025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001106117582035-11-26U-42232025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001110015782035-11-26Drug substance, Drug product2025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001110848092035-11-26U-4223Drug substance, Drug product2025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001111986912035-11-26U-42232025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001117390682037-06-23U-42232025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001112305372037-12-25Drug substance, Drug product2025-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219301-001112349392039-01-26U-4223Drug product2025-07-296a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219301-001NCE2030-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N219301-001ODE-5342032-07-0384e616aacf4f…
2026-08-18 06:07:402026-07N219301-001NCE2030-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N219301-001ODE-5342032-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219301-001NCE2030-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219301-001NCE2030-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219301-001NCE2030-07-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219301-001NCE2030-07-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219301-001ODE-5342032-07-03a50c72e98297…

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
IngredientStrength
SEBETRALSTAT300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O5ZD2TU2B7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2717949Internal RxNorm lookup
2717955Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d145e2f-8e7e-2e90-e063-6294a90a4449Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82928-300-01EKTERLY1 in 1 BLISTER PACKTABLET14
82928-300-02EKTERLY2 in 1 BLISTER PACKTABLET24
82928-300-04EKTERLY4 in 1 CARTONTABLET44
82928-300-05EKTERLY2 in 1 CARTONTABLET24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82928-300-01EA - Each82928-300c318a31c-0c1a-4b38-a69f-24aa6e252fbf12025-08-11
82928-300-04EA - Each82928-3005b817e44-15e6-49c1-a0b9-e56ffad520c112025-08-11

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EKTERLYSEBETRALSTATKalVista Pharmaceuticals Ltd1d145e2f-8e7e-2e90-e063-6294a90a44492026-04-01Adverse reactionsExact identifier
application applno (NDA): 219301
application number: NDA219301
ndc (package): 82928-300-04
ndc (product): 82928-300
ndc11 (package): 82928030004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717955Ekterly 300 MG Oral TabletPSN1d145e2f-8e7e-2e90-e063-6294a90a44494
2717949sebetralstat 300 MG Oral TabletPSN1d145e2f-8e7e-2e90-e063-6294a90a44494
2717955sebetralstat 300 MG Oral Tablet [Ekterly]SBD1d145e2f-8e7e-2e90-e063-6294a90a44494
2717949sebetralstat 300 MG Oral TabletSCD1d145e2f-8e7e-2e90-e063-6294a90a44494
2717955Ekterly 300 MG Oral TabletSY1d145e2f-8e7e-2e90-e063-6294a90a44494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82928-300-04829280300044 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01) 4 blister pack2025-07-03NoNoCurrent