mitoXANTRONE

Product NDC: 0703-4685
11-digit product format: 007034685
Labeler code: 0703
Product ID: 0703-4685_4e9bdbc5-b9de-4e8e-9b0c-2f969a5a9c1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mitoXANTRONE
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Teva Parenteral Medicines, Inc.
Application: ANDA077356
Marketing category: ANDA
Marketing start: 2006-04-11
Marketing end: 0000-00-00
Substance: MITOXANTRONE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0703-4685		D	Discontinued by firm		2026-08-03
excluded package	package	0703-4685	0703-4685-01	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0703-4685-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0703-4685-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0703-4685-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0703-4685-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0703-4685-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0703-4685-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0703-4685-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0703-4685-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0703-4685-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0703-4685-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0703-4685-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0703-4685-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077356-001	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077356-002	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077356-003	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077356-001	AP
A077356-002	AP
A077356-003	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 4 · 123 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	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077356-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A077356-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077356-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077356-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077356-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077356-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077356-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077356-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077356-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077356-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077356-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077356-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077356-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077356-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077356-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077356-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077356-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077356-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077356-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077356-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077356-001	AP	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0703-4685-01	ML - Milliliter	0703-4685	da63468f-eb67-4f34-9bfd-11fd9dc9cdca	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MITOXANTRONE HYDROCHLORIDE	ACTIVE INGREDIENT	U6USW86RD0	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4
MITOXANTRONE	ACTIVE MOIETY	BZ114NVM5P	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4
SODIUM ACETATE ANHYDROUS	INACTIVE INGREDIENT	NVG71ZZ7P0	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC]	4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mitoXANTRONE	MITOXANTRONE	Meitheal Pharmaceuticals Inc.	1634528a-30c5-4309-acc8-4c0293ae14ae	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077356 application number: ANDA077356

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U6USW86RD0	MITOXANTRONE HYDROCHLORIDE	70476-82-3	MITOXANTRONE HYDROCHLORIDE
BZ114NVM5P	MITOXANTRONE	65271-80-9	mitoXANTRONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0703-4685-01	00703468501	1 VIAL, MULTI-DOSE in 1 CARTON (0703-4685-01) > 10 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mitoXANTRONE Injection USP (concentrate)	Teva Parenteral Medicines, Inc.	2012-05-31	HUMAN PRESCRIPTION DRUG LABEL	12