Mitoxantrone

Product NDC: 61703-343
11-digit product format: 617030343
Labeler code: 61703
Product ID: 61703-343_8658f2e1-ad36-4ce0-af12-80814bd8bf5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mitoxantrone
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA076871
Marketing category: ANDA
Marketing start: 2006-04-11
Substance: MITOXANTRONE HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076871-001	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11
A076871-002	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11
A076871-003	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	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
A076871-001	AP
A076871-002	AP
A076871-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-002	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-003	MITOXANTRONE HYDROCHLORIDE	EQ 30MG BASE/15ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	2006-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076871-001	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	RS	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	A076871-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076871-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076871-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076871-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076871-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076871-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076871-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076871-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076871-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076871-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076871-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076871-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076871-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076871-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076871-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076871-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076871-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076871-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076871-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076871-001	AP	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitoxantrone	MITOXANTRONE	Hospira, Inc.	accf9569-4b57-4e83-a7db-4e890a75d1ba	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076871 application number: ANDA076871 ndc (product): 61703-343

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MITOXANTRONE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U6USW86RD0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197989	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
accf9569-4b57-4e83-a7db-4e890a75d1ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61703-343-18	Mitoxantrone	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION, CONCENTRATE	10	25
61703-343-18	Mitoxantrone	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	25
61703-343-65	Mitoxantrone	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	25
61703-343-65	Mitoxantrone	12.5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION, CONCENTRATE	12.5	25
61703-343-66	Mitoxantrone	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1	25
61703-343-66	Mitoxantrone	15 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION, CONCENTRATE	15	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61703-343-18	ML - Milliliter	61703-343	a74a6573-f977-4728-a859-936ac691f512	1	2012-07-24
61703-343-65	ML - Milliliter	61703-343	6948a21d-e717-4125-942b-9211aadf05f0	1	2012-07-24
61703-343-66	ML - Milliliter	61703-343	e7c952ad-62cb-43a8-9bdd-f9c3948752fa	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MITOXANTRONE HYDROCHLORIDE	ACTIVE INGREDIENT	U6USW86RD0	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16
MITOXANTRONE	ACTIVE MOIETY	BZ114NVM5P	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16
WATER	INACTIVE INGREDIENT	059QF0KO0R	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA WORLDWIDE, INC.]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61703-343	MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	24	Current NDC, Legacy NDC, 6 package rows	20250121_accf9569-4b57-4e83-a7db-4e890a75d1ba.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197989	mitoXANTRONE 2 MG/ML Injectable Solution	PSN	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone 2 MG/ML Injectable Solution	SCD	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone (as mitoxantrone hydrochloride) 2 MG/ML Injectable Solution	SY	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone 20 MG per 10 ML Injectable Solution	SY	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone 25 MG per 12.5 ML Injectable Solution	SY	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone 30 MG per 15 ML Injectable Solution	SY	accf9569-4b57-4e83-a7db-4e890a75d1ba	25
197989	mitoxantrone 45 MG per 22.5 ML Injectable Solution	SY	accf9569-4b57-4e83-a7db-4e890a75d1ba	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61703-343-18	61703034318	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) / 10 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current
61703-343-65	61703034365	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) / 12.5 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current
61703-343-66	61703034366	1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) / 15 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)	Hospira, Inc. \| Zydus Hospira Oncology Private Limited	2025-07-14	HUMAN PRESCRIPTION DRUG LABEL	25