FDA.reportPublic FDA data

Mitomycin

Product NDC
68001-389
11-digit product format
680010389
Labeler code
68001
Product ID
68001-389_c455e123-6115-d234-e053-2995a90a2e93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mitomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA064144
Marketing category
ANDA
Marketing start
2019-05-14
Substance
MITOMYCIN
Active strength
5 mg/10mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MITOMYCIN5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50SG953SK6
Rxcui1740894, 1740898, 1740900

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
68001-389-28Mitomycin10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,102
68001-389-36Mitomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-389-28EA - Each68001-389c4acfcde-d8c7-4dc1-afee-4f3ae5aa684012019-06-19
68001-389-36EA - Each68001-3896923e0e0-fa4d-4590-af6d-796a486dff6012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-389MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20210617_aad9a9a0-7204-452a-8b9b-6d625c4ee021.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740900mitoMYcin 20 MG InjectionPSNaad9a9a0-7204-452a-8b9b-6d625c4ee0212
1740898mitoMYcin 40 MG InjectionPSNaad9a9a0-7204-452a-8b9b-6d625c4ee0212
1740894mitoMYcin 5 MG InjectionPSNaad9a9a0-7204-452a-8b9b-6d625c4ee0212
1740900mitomycin 20 MG InjectionSCDaad9a9a0-7204-452a-8b9b-6d625c4ee0212
1740898mitomycin 40 MG InjectionSCDaad9a9a0-7204-452a-8b9b-6d625c4ee0212
1740894mitomycin 5 MG InjectionSCDaad9a9a0-7204-452a-8b9b-6d625c4ee0212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-389-286800103892810 mL in 1 VIAL10 mlHistorical
68001-389-36680010389361 VIAL in 1 CARTON (68001-389-36) / 10 mL in 1 VIAL (68001-389-28) 1 vial2019-05-140000-00-00NoNoCurrent