DEXRAZOXANE

Product NDC: 55150-434
11-digit product format: 551500434
Labeler code: 55150
Product ID: 55150-434_cb72203a-0b09-42d5-bf51-7f479feb3adb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXRAZOXANE
Dosage form: KIT
Labeler: AuroMedics Pharma 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.

Application-product, TE code table
Application-product	TE code
A200752-001	AP
A200752-002	AP

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A200752-001	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200752-002	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200752-001	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200752-002	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2011-10-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200752-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200752-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200752-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200752-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200752-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200752-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200752-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200752-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200752-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200752-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200752-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200752-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200752-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200752-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200752-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200752-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200752-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200752-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200752-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200752-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200752-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200752-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200752-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200752-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200752-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200752-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200752-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200752-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200752-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200752-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200752-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200752-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200752-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200752-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200752-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200752-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200752-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200752-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200752-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200752-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: DEXRAZOXANE
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1736585	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cb72203a-0b09-42d5-bf51-7f479feb3adb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
29e688b2-4dc9-4153-a703-360ac9c231b8	Product name	2	20260112
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
0acaa005-650f-0752-3fb2-220e08af175e	Product name	2	20190219
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-434-01	DEXRAZOXANE	01 in 1 PACKAGE	KIT	01		3
55150-434-02	DEXRAZOXANE	01 in 1 PACKAGE	KIT	01		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-434-01	EA - Each	55150-434	5601c4a5-e113-494f-b8a6-e384abc5a270	1	2022-11-07
55150-434-02	EA - Each	55150-434	35d4a90d-d61a-49e9-ac4a-a7043caf2850	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-434	DEXRAZOXANE KIT [EUGIA US LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241109_be9ac1e9-21a9-439a-9029-9f03513220ea.zip
55150-434	DEXRAZOXANE KIT [AUROMEDICS PHARMA LLC]	1	Current NDC, Legacy NDC, 1 package rows	20220721_cb72203a-0b09-42d5-bf51-7f479feb3adb.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXRAZOXANE	DEXRAZOXANE	Eugia US LLC	be9ac1e9-21a9-439a-9029-9f03513220ea	2024-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200752 application number: ANDA200752 ndc (product): 55150-434
DEXRAZOXANE	DEXRAZOXANE	AuroMedics Pharma LLC	cb72203a-0b09-42d5-bf51-7f479feb3adb	2022-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200752 application number: ANDA200752 ndc (product): 55150-434

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
048L81261F	DEXRAZOXANE	24584-09-6	DEXRAZOXANE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736585	dexrazoxane 250 MG Injection	PSN	be9ac1e9-21a9-439a-9029-9f03513220ea	3
1736590	dexrazoxane 500 MG Injection	PSN	be9ac1e9-21a9-439a-9029-9f03513220ea	3
1736585	dexrazoxane 250 MG Injection	SCD	be9ac1e9-21a9-439a-9029-9f03513220ea	3
1736590	dexrazoxane 500 MG Injection	SCD	be9ac1e9-21a9-439a-9029-9f03513220ea	3
1736590	dexrazoxane (as dexrazoxane HCl) 500 MG Injection	SY	be9ac1e9-21a9-439a-9029-9f03513220ea	3
1736585	dexrazoxane 250 MG Injection	PSN	cb72203a-0b09-42d5-bf51-7f479feb3adb	1
1736585	dexrazoxane 250 MG Injection	SCD	cb72203a-0b09-42d5-bf51-7f479feb3adb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-434-01	55150043401	1 KIT in 1 PACKAGE (55150-434-01) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-01) * 25 mL in 1 VIAL (55150-433-01)	1 kit	2016-05-12	0000-00-00	No	No	Current
55150-434-02	55150043402	1 KIT in 1 PACKAGE (55150-434-02) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02) * 25 mL in 1 VIAL (55150-433-02)	1 kit	2016-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXRAZOXANE	Eugia US LLC \| GLAND PHARMA LIMITED	2024-11-02	Human Prescription Drug Label	3
DEXRAZOXANE	AuroMedics Pharma LLC \| GLAND PHARMA LIMITED	2022-07-19	Human Prescription Drug Label	1