NDC 66993-489

Dactinomycin

Dactinomycin

Dactinomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Prasco Laboratories. The primary component is Dactinomycin.

Product ID66993-489_5e1a4e0b-d686-420b-e053-2a91aa0a57ee
NDC66993-489
Product TypeHuman Prescription Drug
Proprietary NameDactinomycin
Generic NameDactinomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-12-04
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA050682
Labeler NamePrasco Laboratories
Substance NameDACTINOMYCIN
Active Ingredient Strength1 mg/mL
Pharm ClassesActinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66993-489-35

12 CARTON in 1 CARTON (66993-489-35) > 1 VIAL, SINGLE-DOSE in 1 CARTON (66993-489-83) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66993-489-35 [66993048935]

Dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA050682
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-04

NDC 66993-489-83 [66993048983]

Dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA050682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-04

Drug Details

Active Ingredients

IngredientStrength
DACTINOMYCIN.5 mg/mL

OpenFDA Data

SPL SET ID:5e1a64c2-283a-51a7-e053-2991aa0af15f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 239179
  • UPC Code
  • 0366993489353
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.