NDC 55292-811

Cosmegen

Dactinomycin

Cosmegen is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Dactinomycin.

Product ID55292-811_137c07d7-e2bf-4f59-8b8f-4ebe119e576d
NDC55292-811
Product TypeHuman Prescription Drug
Proprietary NameCosmegen
Generic NameDactinomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1964-12-10
Marketing CategoryNDA / NDA
Application NumberNDA050682
Labeler NameRECORDATI RARE DISEASES, INC.
Substance NameDACTINOMYCIN
Active Ingredient Strength1 mg/mL
Pharm ClassesActinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55292-811-55

12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1964-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55292-811-55 [55292081155]

Cosmegen INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1964-12-10

Drug Details

Active Ingredients

IngredientStrength
DACTINOMYCIN.5 mg/mL

OpenFDA Data

SPL SET ID:9914e793-a49c-eb00-1ab7-f606c786fe25
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105569
  • 239179
  • Pharmacological Class

    • Actinomycin [EPC]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Protein Synthesis Inhibitors [MoA]
    • Actinomycin [EPC]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Protein Synthesis Inhibitors [MoA]

    NDC Crossover Matching brand name "Cosmegen" or generic name "Dactinomycin"

    NDCBrand NameGeneric Name
    55292-811Cosmegendactinomycin
    39822-2100dactinomycindactinomycin
    42658-008Dactinomycindactinomycin
    55150-431DACTINOMYCINDACTINOMYCIN
    55150-928DACTINOMYCINDACTINOMYCIN
    66993-489DactinomycinDactinomycin
    67457-513DactinomycinDactinomycin
    67457-928DactinomycinDactinomycin
    71288-129DactinomycinDactinomycin

    Trademark Results [Cosmegen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COSMEGEN
    COSMEGEN
    72164543 0759115 Live/Registered
    MERCK & CO., INC.
    1963-03-13
    COSMEGEN
    COSMEGEN
    71669782 0604749 Dead/Expired
    MERCK & CO., INC.
    1954-07-12

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