NDC 68001-391

Mitomycin

Mitomycin

Mitomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Mitomycin.

Product ID68001-391_aad9a9a0-7204-452a-8b9b-6d625c4ee021
NDC68001-391
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA064144
Labeler NameBluePoint Laboratories
Substance NameMITOMYCIN
Active Ingredient Strength40 mg/80mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-391-79

1 VIAL in 1 BOX, UNIT-DOSE (68001-391-79) > 80 mL in 1 VIAL (68001-391-80)
Marketing Start Date2019-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-391-80 [68001039180]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-14

NDC 68001-391-79 [68001039179]

Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA064144
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-14

Drug Details

Active Ingredients

IngredientStrength
MITOMYCIN40 mg/80mL

OpenFDA Data

SPL SET ID:aad9a9a0-7204-452a-8b9b-6d625c4ee021
Manufacturer
UNII

Pharmacological Class

  • Alkylating Activity [MoA]
  • Alkylating Drug [EPC]
  • Alkylating Activity [MoA]
  • Alkylating Drug [EPC]