Home NDC 55150-437-01 DEXRAZOXANE
Product NDC 55150-437
Requested package NDC 55150-437-01
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 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 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.
Product history page 1 of 3 · 86 observed 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 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2011-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200752-001 DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2011-10-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200752-002 DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2011-10-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 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
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 · 2 matching rows.
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