Dexrazoxane Hydrochloride

Product NDC: 67457-208
11-digit product format: 674570208
Labeler code: 67457
Product ID: 67457-208_d0adbbbb-703c-47d2-85d3-e2f8949b81fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexrazoxane
Dosage form: KIT
Labeler: Mylan Institutional LLC
Application: ANDA200752
Marketing category: ANDA
Marketing start: 2011-11-18
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67457-208		D	Discontinued by firm		2026-07-31
excluded package	package	67457-208	67457-208-50	D	Discontinued by firm		2026-07-31

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.

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.

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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-208-50	EA - Each	67457-208	d289e59e-97d5-4f9d-93f4-1bf01263765d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXRAZOXANE HYDROCHLORIDE	ACTIVE INGREDIENT	5346058Q7S	DEXRAZOXANE HYDROCHLORIDE (DEXRAZOXANE) KIT [MYLAN INSTITUTIONAL LLC]	5
DEXRAZOXANE	ACTIVE MOIETY	048L81261F	DEXRAZOXANE HYDROCHLORIDE (DEXRAZOXANE) KIT [MYLAN INSTITUTIONAL LLC]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DEXRAZOXANE HYDROCHLORIDE (DEXRAZOXANE) KIT [MYLAN INSTITUTIONAL LLC]	5

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-208-50	67457020850	1 KIT in 1 PACKAGE (67457-208-50) * 50 mL in 1 VIAL (67457-205-50) * 50 mL in 1 VIAL, SINGLE-DOSE (67457-209-50)	1 kit	2011-11-18	0000-00-00	No	No	Current