Home NDC 42358-329 Zycubo
Product NDC 42358-329
11-digit product format 423580329
Labeler code 42358
Product ID 42358-329_bfd40890-37a6-4847-9b2d-6e6966b6af01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name copper histidinate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route SUBCUTANEOUS
Labeler Sentynl Therapeutics, Inc.
Application NDA211241
Marketing category NDA
Marketing start 2026-01-12
Substance COPPER HISTIDINATE
Active strength 2.9 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 42 .
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 N211241-001 ZYCUBO COPPER HISTIDINATE 2.9MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-01-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211241-001 NCE 2031-01-12 N211241-001 ODE-520 2033-01-12
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 2026-08-18 06:07:40 2026-07 N211241-001 ZYCUBO 2.9MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211241-001 ZYCUBO 2.9MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-01-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211241-001 ZYCUBO 2.9MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-01-12 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N211241-001 NCE 2031-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211241-001 ODE-520 2033-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211241-001 NCE 2031-01-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211241-001 NCE 2031-01-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211241-001 ODE-520 2033-01-12 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Zycubo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COPPER HISTIDINATE 2.9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9078K3MO9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2732219 Internal RxNorm lookup 2732224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42358-329-01 Zycubo 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2 42358-329-01 Zycubo 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 2
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zycubo COPPER HISTIDINATE Sentynl Therapeutics, Inc. e3aeefc2-f44d-4337-9c2e-3dba44a89e48 2026-01-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 211241 application number: NDA211241 ndc (product): 42358-329
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42358-329-01 42358032901 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS 2026-01-26 No No Current