Home NDC 60505-6423 EVDI
Product NDC 60505-6423
11-digit product format 605056423
Labeler code 60505
Product ID 60505-6423_63341f3d-2380-37b9-2969-4022718367c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trabectedin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Apotex Corp.
Application NDA220837
Marketing category NDA
Marketing start 2026-06-30
Substance TRABECTEDIN
Active strength .05 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220837-001 EVDI TRABECTEDIN 1MG/20ML (0.05MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-05-01
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220837-001 12303506 2043-02-18 Drug product 2026-05-07
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 N220837-001 EVDI 1MG/20ML (0.05MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220837-001 EVDI 1MG/20ML (0.05MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-05-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220837-001 EVDI 1MG/20ML (0.05MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-05-01 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 N220837-001 12303506 2043-02-18 Drug product 2026-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220837-001 12303506 2043-02-18 Drug product 2026-05-07 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220837-001 12303506 2043-02-18 Drug product 2026-05-07 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 EVDI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRABECTEDIN .05 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ID0YZQ2TCP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2745754 Internal RxNorm lookup 2745760 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 Marketing start Sample Exclude flag Status 60505-6423-0 60505642300 1 VIAL, SINGLE-USE in 1 CARTON (60505-6423-0) / 20 mL in 1 VIAL, SINGLE-USE 2026-06-30 No No Current