mitoXANTRONE

Product NDC
0703-4680
Requested package NDC
0703-4680-01
11-digit product format
007034680
Labeler code
0703
Product ID
0703-4680_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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0703-46800703-4680-01DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077356-001MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11
A077356-002MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11
A077356-003MITOXANTRONE HYDROCHLORIDEMITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077356-001AP
A077356-002AP
A077356-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-002MITOXANTRONE HYDROCHLORIDEEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-003MITOXANTRONE HYDROCHLORIDEEQ 30MG BASE/15ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077356-001MITOXANTRONE HYDROCHLORIDEEQ 20MG BASE/10ML (EQ 2MG BASE/ML)INJECTABLE / INJECTIONAP2006-04-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077356-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077356-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077356-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077356-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077356-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077356-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077356-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077356-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077356-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077356-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077356-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077356-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077356-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077356-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077356-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077356-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077356-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077356-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077356-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077356-001AP18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-4680-01ML - Milliliter0703-4680505f1aa2-1662-4cbc-b9e9-314eca171cd512012-07-24

DailyMed Socrata Ingredients#

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mitoXANTRONEMITOXANTRONEMeitheal Pharmaceuticals Inc.1634528a-30c5-4309-acc8-4c0293ae14ae2025-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077356
application number: ANDA077356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4680-01007034680011 VIAL, MULTI-DOSE in 1 CARTON (0703-4680-01) > 12.5 mL in 1 VIAL, MULTI-DOSE2006-04-110000-00-00NoNoCurrent