FDA.reportPublic FDA data

MITOMYCIN

Product NDC
55150-452
Requested package NDC
55150-452-01
11-digit product format
551500452
Labeler code
55150
Product ID
55150-452_f5a010cf-5954-4e6d-acfa-fb414efdf471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MITOMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA216732
Marketing category
ANDA
Marketing start
2023-10-30
Substance
MITOMYCIN
Active strength
40 mg/80mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216732-001MITOMYCINMITOMYCIN5MG/VIALINJECTABLE / INJECTION2023-10-30
A216732-002MITOMYCINMITOMYCIN20MG/VIALINJECTABLE / INJECTION2023-10-30
A216732-003MITOMYCINMITOMYCIN40MG/VIALINJECTABLE / INJECTION2023-10-30

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216732-001MITOMYCIN5MG/VIALINJECTABLE / INJECTION2023-10-30a50c72e98297…
2026-08-01 22:54:322026-06A216732-002MITOMYCIN20MG/VIALINJECTABLE / INJECTION2023-10-30a50c72e98297…
2026-08-01 22:54:322026-06A216732-003MITOMYCIN40MG/VIALINJECTABLE / INJECTION2023-10-30a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MITOMYCINMITOMYCINBluePoint Laboratories57129df7-d6b1-419e-90ec-54f9b5182e7c2024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216732
application number: ANDA216732
MITOMYCINMITOMYCINEugia US LLCf5a010cf-5954-4e6d-acfa-fb414efdf4712023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216732
application number: ANDA216732
ndc (package): 55150-452-01
ndc (product): 55150-452
ndc11 (package): 55150045201

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MITOMYCIN40 mg/80mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50SG953SK6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1740894Internal RxNorm lookup
1740898Internal RxNorm lookup
1740900Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5a010cf-5954-4e6d-acfa-fb414efdf471Available on FDA.report

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
55150-452-01MITOMYCIN1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
55150-452-01MITOMYCIN80 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-452-01EA - Each55150-45213122827-67c8-4360-8e72-3b3f6411d2c412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-452MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20231101_f5a010cf-5954-4e6d-acfa-fb414efdf471.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740900mitoMYcin 20 MG InjectionPSNf5a010cf-5954-4e6d-acfa-fb414efdf4711
1740898mitoMYcin 40 MG InjectionPSNf5a010cf-5954-4e6d-acfa-fb414efdf4711
1740894mitoMYcin 5 MG InjectionPSNf5a010cf-5954-4e6d-acfa-fb414efdf4711
1740900mitomycin 20 MG InjectionSCDf5a010cf-5954-4e6d-acfa-fb414efdf4711
1740898mitomycin 40 MG InjectionSCDf5a010cf-5954-4e6d-acfa-fb414efdf4711
1740894mitomycin 5 MG InjectionSCDf5a010cf-5954-4e6d-acfa-fb414efdf4711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55150-452-01551500452011 VIAL, SINGLE-DOSE in 1 CARTON (55150-452-01) / 80 mL in 1 VIAL, SINGLE-DOSE2023-10-30NoNoCurrent