NDC 39822-2100

dactinomycin

Dactinomycin

dactinomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Dactinomycin.

Product ID39822-2100_0889a20b-658e-4dba-a2e7-65c8b2e5a229
NDC39822-2100
Product TypeHuman Prescription Drug
Proprietary Namedactinomycin
Generic NameDactinomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA203999
Labeler NameX-GEN Pharmaceuticals, 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 Through2020-12-31

Packaging

NDC 39822-2100-2

1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) > 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)
Marketing Start Date2019-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39822-2100-1 [39822210001]

dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA203999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31

NDC 39822-2100-2 [39822210002]

dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA203999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
DACTINOMYCIN.5 mg/mL

OpenFDA Data

SPL SET ID:efe03d73-eb11-45ff-a3cb-09a540ed352f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239179
  • Pharmacological Class

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

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

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

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