ENSACOVE

Product NDC
83076-1100
Requested package NDC
83076-1100-6
11-digit product format
830761100
Labeler code
83076
Product ID
83076-1100_17196ce1-224e-4359-ac54-39e035def74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ensartinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Xcovery Holdings, Inc.
Application
NDA218171
Marketing category
NDA
Marketing start
2025-04-30
Substance
ENSARTINIB HYDROCHLORIDE
Active strength
100 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218171-001ENSACOVEENSARTINIB HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALRLD2024-12-18
N218171-002ENSACOVEENSARTINIB HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218171-00185519952029-02-09Drug substance2025-01-17
N218171-00192967242029-06-18U-4099Drug substance2025-01-17
N218171-00191269472031-11-29Drug substance2025-01-17
N218171-001108997442037-06-01U-4099Drug substance2025-01-17
N218171-00285519952029-02-09Drug substance2025-01-17
N218171-00292967242029-06-18U-4099Drug substance2025-01-17
N218171-00291269472031-11-29Drug substance2025-01-17
N218171-002108997442037-06-01U-4099Drug substance2025-01-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218171-001NCE2029-12-18
N218171-002NCE2029-12-18

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
2026-10-15 13:18:302026-09N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18c2088c7a36db…
2026-10-15 13:18:302026-09N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18c2088c7a36db…
2026-09-14 22:38:342026-08N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-1803ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218171-001ENSACOVEEQ 25MG BASECAPSULE / ORALRLD2024-12-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218171-002ENSACOVEEQ 100MG BASECAPSULE / ORALRLD, RS2024-12-18a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N218171-00185519952029-02-09Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-00192967242029-06-18U-4099Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-00191269472031-11-29Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-001108997442037-06-01U-4099Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-00285519952029-02-09Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-00292967242029-06-18U-4099Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-00291269472031-11-29Drug substance2025-01-17c2088c7a36db…
2026-10-15 13:18:302026-09N218171-002108997442037-06-01U-4099Drug substance2025-01-17c2088c7a36db…
2026-09-14 22:38:342026-08N218171-00185519952029-02-09Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-00192967242029-06-18U-4099Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-00191269472031-11-29Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-001108997442037-06-01U-4099Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-00285519952029-02-09Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-00292967242029-06-18U-4099Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-00291269472031-11-29Drug substance2025-01-1784e616aacf4f…
2026-09-14 22:38:342026-08N218171-002108997442037-06-01U-4099Drug substance2025-01-1784e616aacf4f…
2026-08-18 06:07:402026-07N218171-00185519952029-02-09Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-00192967242029-06-18U-4099Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-00191269472031-11-29Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-001108997442037-06-01U-4099Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-00285519952029-02-09Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-00292967242029-06-18U-4099Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-00291269472031-11-29Drug substance2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-002108997442037-06-01U-4099Drug substance2025-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218171-00185519952029-02-09Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-00192967242029-06-18U-4099Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-00191269472031-11-29Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-001108997442037-06-01U-4099Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-00285519952029-02-09Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-00292967242029-06-18U-4099Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-00291269472031-11-29Drug substance2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-002108997442037-06-01U-4099Drug substance2025-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00185519952029-02-09Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00192967242029-06-18U-4099Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00191269472031-11-29Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-001108997442037-06-01U-4099Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00285519952029-02-09Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00292967242029-06-18U-4099Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-00291269472031-11-29Drug substance2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-002108997442037-06-01U-4099Drug substance2025-01-1731067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N218171-001NCE2029-12-18c2088c7a36db…
2026-10-15 13:18:302026-09N218171-002NCE2029-12-18c2088c7a36db…
2026-09-14 22:38:342026-08N218171-001NCE2029-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N218171-002NCE2029-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N218171-001NCE2029-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N218171-002NCE2029-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218171-001NCE2029-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218171-002NCE2029-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-001NCE2029-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218171-002NCE2029-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N218171-001NCE2029-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218171-002NCE2029-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218171-001NCE2029-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218171-002NCE2029-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218171-001NCE2029-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218171-002NCE2029-12-18b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218171-001NCE2029-12-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218171-002NCE2029-12-18a50c72e98297…

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
ENSACOVE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENSARTINIB HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C2FR6VT1BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2712634Internal RxNorm lookup
2712640Internal RxNorm lookup
2712642Internal RxNorm lookup
2712644Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e1b2f79-678a-472a-b924-66909c8a4b2eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14475d2d-5e73-444b-bc17-f9e9dc270498Product name120250814
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83076-1100-6ENSACOVE60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83076-1100-6EA - Each83076-1100861b45c5-4827-4ebe-8901-a49e62ed424312025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83076-1100ENSACOVE (ENSARTINIB) CAPSULE [XCOVERY HOLDINGS, INC.]3Current NDC, 1 package rows20250430_1e1b2f79-678a-472a-b924-66909c8a4b2e.zip

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
ENSACOVEENSARTINIBXcovery Holdings, Inc.1e1b2f79-678a-472a-b924-66909c8a4b2e2026-02-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 218171
application number: NDA218171
ndc (package): 83076-1100-6
ndc (product): 83076-1100
ndc11 (package): 83076110006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712640Ensacove 100 MG Oral CapsulePSN1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712644Ensacove 25 MG Oral CapsulePSN1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712634ensartinib 100 MG Oral CapsulePSN1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712642ensartinib 25 MG Oral CapsulePSN1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712640ensartinib 100 MG Oral Capsule [Ensacove]SBD1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712644ensartinib 25 MG Oral Capsule [Ensacove]SBD1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712634ensartinib 100 MG Oral CapsuleSCD1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712642ensartinib 25 MG Oral CapsuleSCD1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712640Ensacove 100 MG (as ensartinib hydrochloride 113 MG) Oral CapsuleSY1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712644Ensacove 25 MG (as ensartinib hydrochloride 28.25 MG) Oral CapsuleSY1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712634ensartinib 100 MG (as ensartinib hydrochloride 113 MG) Oral CapsuleSY1e1b2f79-678a-472a-b924-66909c8a4b2e5
2712642ensartinib 25 MG (as ensartinib hydrochloride 28.25 MG) Oral CapsuleSY1e1b2f79-678a-472a-b924-66909c8a4b2e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83076-1100-68307611000660 CAPSULE in 1 BOTTLE (83076-1100-6) 60 capsule2025-04-30NoNoCurrent