Home NDC 55150-437 DEXRAZOXANE
Product NDC 55150-437
11-digit product format 551500437
Labeler code 55150
Product ID 55150-437_f0a2a9ff-2f1f-481b-96c8-404e9d4a60fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXRAZOXANE
Dosage form KIT
Labeler Eugia US LLC
Application ANDA200752
Marketing category ANDA
Marketing start 2016-05-12
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A200752-001 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 A200752-002 DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-01 22:54:32 2026-06 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A200752-001 AP 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A200752-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base DEXRAZOXANE
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1736585 Internal RxNorm lookup 1736590 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 55150-437-01 DEXRAZOXANE 01 in 1 PACKAGE KIT 01 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-437 DEXRAZOXANE KIT [EUGIA US LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241109_be9ac1e9-21a9-439a-9029-9f03513220ea.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55150-437-01 55150043701 1 KIT in 1 PACKAGE (55150-437-01) * 50 mL in 1 VIAL, SINGLE-DOSE (55150-435-01) * 50 mL in 1 VIAL (55150-436-01) 1 kit 2016-05-12 0000-00-00 No No Current