FDA.reportPublic FDA data

Mitomycin C

Manufacturer
AX Pharmaceutical Corp
Effective date
2022-10-05
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:33

Label at a glance#

ProductMitomycin C
Active ingredientMITOMYCIN
Label structure1 sections

Label contents#

Full prescribing information#

Mitomycin C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61a18a7f-d50a-4423-aa08-6a8f710ed5daProduct name720250722
1f4d6d8c-234a-4bf6-b123-695584719ba0Product name120200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-092-01Mitomycin C5 g in 1 JARPOWDER52
73377-092-02Mitomycin C10 g in 1 JARPOWDER102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-092MITOMYCIN C POWDER [AX PHARMACEUTICAL CORP]22 package rows20221007_738a8da3-e7ff-4443-8160-ec0758ae4bed.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-09273377-092-01, 73377-092-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MITOMYCIN50SG953SK6ACTIB

Source Document#

Source XML

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MitomycinMITOMYCINHikma Pharmaceuticals USA Inc.5917f7a7-cd20-407b-8dda-9fd58c5f47a62026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINBryant Ranch Prepack5f41676f-f687-47db-871c-35bbf2447a982025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
JELMYTOMITOMYCINUroGen Pharma, Inc.3d3d5053-5427-4a68-a40b-edb60699521e2025-07-09Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
ZUSDURIMITOMYCINUroGen Pharma, Inc8dc68793-bca8-4e3d-b672-622961b582552025-06-20Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitosolMITOMYCINMobius Therapeutics LLC244002c6-c61d-43fe-9326-0727971139792025-04-23Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINAccord Healthcare, Inc.ff676355-313d-4575-8f2f-e4a1e95274772025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MUTAMYCINMITOMYCINAccord BioPharma Inc.cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e2025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINBryant Ranch Prepack799a06b1-7697-42a3-b31a-c9d621b34f6f2025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINBluePoint Laboratories57129df7-d6b1-419e-90ec-54f9b5182e7c2024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINEugia US LLCf5a010cf-5954-4e6d-acfa-fb414efdf4712023-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINArchis Pharma LLCcef5026c-8bc3-4428-a178-6effff4dcb3f2023-09-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINArchis Pharma LLC2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f2023-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINSagent Pharmaceuticals10c41a58-c305-4240-80d2-caa0704126482023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINSagent Pharmaceuticals0171a1c8-c474-4ec1-a11d-6b93a21ca4602023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINFresenius Kabi USA, LLCbc937e3d-7167-49a5-b6b1-004b0f89d8c42023-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINFresenius Kabi USA, LLC6a4fbc96-e35d-41c2-91fc-4b48220bdba22023-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINGland Pharma Limited2528999b-9f09-4e64-89fc-1e3d69c2d0b62022-11-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MitomycinMITOMYCINHikma Pharmaceuticals USA Inc.fde1e4e9-fc67-4e84-aa31-0cf0e73e19a82022-09-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINMeitheal Pharmaceuticals Inc.9dd0e3f2-0938-4c57-8d09-040b5405b44f2022-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN
MITOMYCINMITOMYCINGland Pharma Limited650d3024-b9a9-4018-8115-0951acfe31452021-10-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MITOMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.