Dexrazoxane

Product NDC: 51991-942
Requested package NDC: 51991-942-98
11-digit product format: 519910942
Labeler code: 51991
Product ID: 51991-942_3cf93d43-a779-4d9a-9ef5-1648e6ffa278
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexrazoxane Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA207321
Marketing category: ANDA
Marketing start: 2016-12-05
Marketing end: 0000-00-00
Substance: DEXRAZOXANE HYDROCHLORIDE
Active strength: 500 mg/50mL
Pharmacologic classes: Cytoprotective Agent [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51991-942	51991-942-98	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A207321-001	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-28
A207321-002	DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP		2019-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207321-001	AP
A207321-002	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 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A207321-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207321-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207321-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207321-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207321-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207321-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207321-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207321-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207321-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207321-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207321-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207321-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207321-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207321-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207321-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207321-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207321-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207321-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207321-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207321-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207321-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207321-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207321-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207321-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207321-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207321-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207321-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207321-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207321-001	AP	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-942-98	EA - Each	51991-942	6de6336e-d5c5-4b15-b27f-cca4b2f2111e	1	2017-10-13

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Almaject, Inc.	9cbd2987-10bb-eceb-153d-ee7be1ed0c84	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Almaject, Inc.	e9550d22-6069-a6de-9968-6a18c9e0448f	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Gland Pharma Limited	c9c625fc-8852-4ed4-bcf2-63f46a706782	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Fosun Pharma USA Inc.	c1d98fbe-5fd9-4518-b1a5-fac92e32928f	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5346058Q7S	DEXRAZOXANE HYDROCHLORIDE	1263283-43-7	DEXRAZOXANE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-942-98	51991094298	1 VIAL, SINGLE-DOSE in 1 CARTON (51991-942-98) > 50 mL in 1 VIAL, SINGLE-DOSE	2017-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexrazoxane	Breckenridge Pharmaceutical, Inc. \| Gland Pharma Limited	2023-01-24	HUMAN PRESCRIPTION DRUG LABEL	3