NDC 68083-502

MITOMYCIN

Mitomycin

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

Product ID68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853
NDC68083-502
Product TypeHuman Prescription Drug
Proprietary NameMITOMYCIN
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-11-22
Marketing CategoryANDA /
Application NumberANDA216648
Labeler NameGland Pharma Limited
Substance NameMITOMYCIN
Active Ingredient Strength40 mg/80mL
Pharm ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-502-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) > 80 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-11-22
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "MITOMYCIN" or generic name "Mitomycin"

NDCBrand NameGeneric Name
0143-9135MitomycinMitomycin
0143-9136MitomycinMitomycin
0143-9279MitomycinMitomycin
0143-9280MitomycinMitomycin
16729-108MitomycinMitomycin
16729-115MitomycinMitomycin
16729-116MitomycinMitomycin
16729-246MitomycinMitomycin
16729-247MitomycinMitomycin
16729-248MitomycinMitomycin
67457-518MitomycinMitomycin
67457-519MitomycinMitomycin
67457-520MitomycinMitomycin
67457-995MitomycinMitomycin
67457-996MitomycinMitomycin
67457-997MitomycinMitomycin
68001-389MitomycinMitomycin
68001-390MitomycinMitomycin
68001-391MitomycinMitomycin
68083-483MITOMYCINMITOMYCIN
68083-484MITOMYCINMITOMYCIN
68083-502MITOMYCINMITOMYCIN
71288-137MITOMYCINMITOMYCIN
71288-138MITOMYCINMITOMYCIN
69605-103JELMYTOmitomycin
49771-002Mitosolmitomycin
69448-001MUTAMYCINMitomycin
69448-002MUTAMYCINMitomycin
69448-003MUTAMYCINMitomycin
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