Home NDC 59630-711 XOCOVA
Product NDC 59630-711
11-digit product format 596300711
Labeler code 59630
Product ID 59630-711_96185ce1-2b27-43a1-9b24-e76cbc91a235
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ensitrelvir
Dosage form TABLET
Route ORAL
Labeler Shionogi Inc.
Application NDA220442
Marketing category NDA
Marketing start 2026-07-02
Substance ENSITRELVIR
Active strength 125 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 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 N220442-001 XOCOVA ENSITRELVIR 125MG TABLET / ORAL RLD, RS 2026-05-29
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220442-001 9150546 2030-12-12 Drug substance, Drug product 2026-06-26 N220442-001 11814368 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 N220442-001 12559474 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220442-001 NCE 2031-05-29
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 N220442-001 XOCOVA 125MG TABLET / ORAL RLD, RS 2026-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220442-001 XOCOVA 125MG TABLET / ORAL RLD, RS 2026-05-29 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220442-001 XOCOVA 125MG TABLET / ORAL RLD, RS 2026-05-29 a50c72e98297…
Observed Orange Book patent history# 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 N220442-001 9150546 2030-12-12 Drug substance, Drug product 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220442-001 11814368 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220442-001 12559474 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220442-001 9150546 2030-12-12 Drug substance, Drug product 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220442-001 11814368 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220442-001 12559474 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220442-001 9150546 2030-12-12 Drug substance, Drug product 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220442-001 11814368 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220442-001 12559474 2042-05-01 U-4553 Drug substance, Drug product 2026-06-26 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N220442-001 NCE 2031-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220442-001 NCE 2031-05-29 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220442-001 NCE 2031-05-29 a50c72e98297…
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 XOCOVA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSITRELVIR 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PX665RAA3H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2745993 Internal RxNorm lookup 2745999 Internal RxNorm lookup 2746000 Internal RxNorm lookup 2746001 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59630-711-07 59630071107 1 BLISTER PACK in 1 CARTON (59630-711-07) / 7 TABLET in 1 BLISTER PACK 1 blister pack 2026-07-02 No No Current