Dexrazoxane

Product NDC: 68083-195
11-digit product format: 680830195
Labeler code: 68083
Product ID: 68083-195_31a8c608-3ad6-44fe-aec8-621a8b991677
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexrazoxane for Injection
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA207321
Marketing category: ANDA
Marketing start: 2016-12-05
Substance: DEXRAZOXANE HYDROCHLORIDE
Active strength: 500 mg/50mL
Pharmacologic classes: Cytoprotective Agent [EPC]
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
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 3 · 82 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
2026-09-14 22:38:34	2026-08	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207321-001	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207321-002	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2019-12-16	`caaa826d4ba7…`
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…`

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
2026-09-14 22:38:34	2026-08	A207321-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207321-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207321-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207321-002	AP	1	`caaa826d4ba7…`
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…`

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXRAZOXANE HYDROCHLORIDE	500 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5346058Q7S	Internal UNII lookup

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c9c625fc-8852-4ed4-bcf2-63f46a706782	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
0acaa005-650f-0752-3fb2-220e08af175e	Product name	2	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-195-01	Dexrazoxane	50 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	50		6
68083-195-01	Dexrazoxane	01 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	01		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-195	DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20231214_c9c625fc-8852-4ed4-bcf2-63f46a706782.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 · 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	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207321 application number: ANDA207321
Dexrazoxane	DEXRAZOXANE FOR INJECTION	Almaject, Inc.	e9550d22-6069-a6de-9968-6a18c9e0448f	2025-08-01	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 ndc (product): 68083-195
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736585	dexrazoxane 250 MG Injection	PSN	c9c625fc-8852-4ed4-bcf2-63f46a706782	6
1736590	dexrazoxane 500 MG Injection	PSN	c9c625fc-8852-4ed4-bcf2-63f46a706782	6
1736585	dexrazoxane 250 MG Injection	SCD	c9c625fc-8852-4ed4-bcf2-63f46a706782	6
1736590	dexrazoxane 500 MG Injection	SCD	c9c625fc-8852-4ed4-bcf2-63f46a706782	6
1736590	dexrazoxane (as dexrazoxane HCl) 500 MG Injection	SY	c9c625fc-8852-4ed4-bcf2-63f46a706782	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-195-01	68083019501	1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL	1 vial	2016-12-05	0000-00-00	No	No	Current