NDC 71288-107

Bleomycin

Bleomycin Sulfate

Bleomycin is a Intramuscular; Intrapleural; Intravenous; Subcutaneous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Bleomycin Sulfate.

Product ID71288-107_ae0d7fba-937e-42d1-b7f5-ae6f7b860bc4
NDC71288-107
Product TypeHuman Prescription Drug
Proprietary NameBleomycin
Generic NameBleomycin Sulfate
Dosage FormPowder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA205030
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameBLEOMYCIN SULFATE
Active Ingredient Strength30 [USP'U]/1
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71288-107-20

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-107-20) > 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-107-20 [71288010720]

Bleomycin POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205030
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
BLEOMYCIN SULFATE30 [USP'U]/1

OpenFDA Data

SPL SET ID:640602f9-a7df-46f0-a9b1-19c471008bee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726676
  • 1726673
  • Pharmacological Class

    • Cytoprotective Agent [EPC]
    • Cytoprotective Agent [EPC]

    NDC Crossover Matching brand name "Bleomycin" or generic name "Bleomycin Sulfate"

    NDCBrand NameGeneric Name
    0143-9240BleomycinBleomycin
    0143-9241BleomycinBleomycin
    0409-0323BleomycinBLEOMYCIN
    0409-0332BleomycinBLEOMYCIN
    0703-3154BleomycinBleomycin
    0703-3155BleomycinBleomycin
    16714-886BleomycinBleomycin
    16714-908BleomycinBleomycin
    61703-323BleomycinBLEOMYCIN
    61703-332BleomycinBLEOMYCIN
    63323-136BleomycinBLEOMYCIN SULFATE
    63323-137BleomycinBLEOMYCIN SULFATE
    69097-364BleomycinBleomycin
    70121-1567BleomycinBleomycin
    71288-106BleomycinBleomycin Sulfate
    71288-107BleomycinBleomycin Sulfate

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