Mitoxantrone

Product NDC: 63323-132
11-digit product format: 633230132
Labeler code: 63323
Product ID: 63323-132_0b47411d-1c42-4241-9301-4ecc3197470c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MITOXANTRONE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA077496
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	Approval date
A077496-001	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077496-002	MITOXANTRONE HYDROCHLORIDE	MITOXANTRONE HYDROCHLORIDE	EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)	INJECTABLE / INJECTION	AP	2006-04-11
A077496-003	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
A077496-001	AP
A077496-002	AP
A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-002	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	A077496-003	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	A077496-001	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	A077496-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077496-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077496-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077496-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077496-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077496-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077496-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077496-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077496-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077496-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077496-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077496-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077496-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077496-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077496-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077496-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077496-001	AP	1	`8072bd15b7f6…`

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
fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	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
63323-132-10	Mitoxantrone	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	7
63323-132-10	Mitoxantrone	1 in 1 BOX	INJECTION, SOLUTION	1	7
63323-132-12	Mitoxantrone	12.5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	12.5	7
63323-132-12	Mitoxantrone	1 in 1 BOX	INJECTION, SOLUTION	1	7
63323-132-15	Mitoxantrone	15 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	15	7
63323-132-15	Mitoxantrone	1 in 1 BOX	INJECTION, SOLUTION	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-132-10	ML - Milliliter	63323-132	fdb9c2b6-1fe2-44f8-953f-b92038c23a18	1	2012-07-24
63323-132-12	ML - Milliliter	63323-132	06e9d72e-3f80-47a2-a4ae-d03666fc827c	1	2012-07-24
63323-132-15	ML - Milliliter	63323-132	ca4d5d1e-bdba-4de0-9a1e-bd9f72893254	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 [FRESENIUS KABI USA, LLC]	4
MITOXANTRONE	ACTIVE MOIETY	BZ114NVM5P	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-132	MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 6 package rows	20241019_fcb8ef8a-f770-4416-8fc5-fa01d98c8eee.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitoxantrone	MITOXANTRONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077496 application number: ANDA077496 ndc (product): 63323-132

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U6USW86RD0	MITOXANTRONE HYDROCHLORIDE	70476-82-3	MITOXANTRONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197989	mitoXANTRONE 2 MG/ML Injectable Solution	PSN	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone 2 MG/ML Injectable Solution	SCD	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone (as mitoxantrone hydrochloride) 2 MG/ML Injectable Solution	SY	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone 20 MG per 10 ML Injectable Solution	SY	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone 25 MG per 12.5 ML Injectable Solution	SY	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone 30 MG per 15 ML Injectable Solution	SY	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7
197989	mitoxantrone 45 MG per 22.5 ML Injectable Solution	SY	fcb8ef8a-f770-4416-8fc5-fa01d98c8eee	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-132-10	63323013210	1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) / 10 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current
63323-132-12	63323013212	1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) / 12.5 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current
63323-132-15	63323013215	1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) / 15 mL in 1 VIAL, MULTI-DOSE	2006-04-11	0000-00-00	No	No	Current