Home NDC 83076-1100-6 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218171-001 ENSACOVE ENSARTINIB HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 N218171-002 ENSACOVE ENSARTINIB HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18
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 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218171-001 NCE 2029-12-18 N218171-002 NCE 2029-12-18
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 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 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218171-001 ENSACOVE EQ 25MG BASE CAPSULE / ORAL RLD 2024-12-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218171-002 ENSACOVE EQ 100MG BASE CAPSULE / ORAL RLD, RS 2024-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 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 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 8551995 2029-02-09 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 9126947 2031-11-29 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-001 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 8551995 2029-02-09 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 9296724 2029-06-18 U-4099 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 9126947 2031-11-29 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218171-002 10899744 2037-06-01 U-4099 Drug substance 2025-01-17 31067a03dcf5…
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 ENSACOVE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSARTINIB HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C2FR6VT1BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2712634 Internal RxNorm lookup 2712640 Internal RxNorm lookup 2712642 Internal RxNorm lookup 2712644 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 83076-1100-6 ENSACOVE 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83076-1100 ENSACOVE (ENSARTINIB) CAPSULE [XCOVERY HOLDINGS, INC.] 3 Current NDC, 1 package rows 20250430_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83076-1100-6 83076110006 60 CAPSULE in 1 BOTTLE (83076-1100-6) 60 capsule 2025-04-30 No No Current