Home NDC 85001-102-01 JIDEYTRO
Product NDC 85001-102
Requested package NDC 85001-102-01
11-digit product format 850010102
Labeler code 85001
Product ID 85001-102_6c672099-2978-474e-b783-973fe94efcfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zidesamtinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Nuvalent, Inc.
Application NDA220185
Marketing category NDA
Marketing start 2026-07-22
Substance ZIDESAMTINIB
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 43 .
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 N220185-001 JIDEYTRO ZIDESAMTINIB 25MG TABLET / ORAL RLD 2026-07-22 N220185-002 JIDEYTRO ZIDESAMTINIB 100MG TABLET / ORAL RLD, RS 2026-07-22
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 N220185-001 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 N220185-001 12054498 2041-05-05 U-4579 2026-07-30 N220185-001 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 N220185-001 12630560 2042-09-30 U-4579 2026-07-30 N220185-002 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 N220185-002 12054498 2041-05-05 U-4579 2026-07-30 N220185-002 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 N220185-002 12630560 2042-09-30 U-4579 2026-07-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220185-001 NCE 2031-07-22 N220185-002 NCE 2031-07-22
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 N220185-001 JIDEYTRO 25MG TABLET / ORAL RLD 2026-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 JIDEYTRO 100MG TABLET / ORAL RLD, RS 2026-07-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220185-001 JIDEYTRO 25MG TABLET / ORAL RLD 2026-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-002 JIDEYTRO 100MG TABLET / ORAL RLD, RS 2026-07-22 caaa826d4ba7…
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 N220185-001 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-001 12054498 2041-05-05 U-4579 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-001 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-001 12630560 2042-09-30 U-4579 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 12054498 2041-05-05 U-4579 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 12630560 2042-09-30 U-4579 2026-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220185-001 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-001 12054498 2041-05-05 U-4579 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-001 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-001 12630560 2042-09-30 U-4579 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-002 11542278 2041-05-05 Drug substance, Drug product 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-002 12054498 2041-05-05 U-4579 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-002 12043626 2042-09-30 Drug substance, Drug product 2026-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220185-002 12630560 2042-09-30 U-4579 2026-07-30 caaa826d4ba7…
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 N220185-001 NCE 2031-07-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220185-002 NCE 2031-07-22 84e616aacf4f…
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 JIDEYTRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIDESAMTINIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MX5KQV5XHC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2748288 Internal RxNorm lookup 2748294 Internal RxNorm lookup 2748296 Internal RxNorm lookup 2748298 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 85001-102-01 85001010201 1 BOTTLE in 1 CARTON (85001-102-01) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-07-22 No No Current