NDC 0409-0323

Bleomycin

Bleomycin

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

Product ID0409-0323_4942d4a5-d2e7-4fdb-8a66-512f3eae7969
NDC0409-0323
Product TypeHuman Prescription Drug
Proprietary NameBleomycin
Generic NameBleomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA065031
Labeler NameHospira, Inc.
Substance NameBLEOMYCIN SULFATE
Active Ingredient Strength30 [USP'U]/1
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0409-0323-20

1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0323-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-0323-20 [00409032320]

Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065031
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-25

Drug Details

Active Ingredients

IngredientStrength
BLEOMYCIN SULFATE30 [USP'U]/1

OpenFDA Data

SPL SET ID:e629ba5a-4e08-4249-9551-af6dbd98a7e4
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"

    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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