67457-513 : Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution


NDC: 67457-513
Labeler: Mylan Institutional LLC
Product Type: Human Prescription Drug
Drug Name: Dactinomycin
Dosage Form: Intravenous Injection, Powder, Lyophilized, for Solution
Application #: ANDA203385
Rev. Date: 


NDC Package Codes:

  • 67457-513-05: 1 VIAL, SINGLE‑DOSE IN 1 CARTON (67457‑513‑05) > 1 ML IN 1 VIAL, SINGLE‑DOSE
  • 67457-513-99: 12 VIAL, SINGLE‑DOSE IN 1 CARTON (67457‑513‑99) > 1 ML IN 1 VIAL, SINGLE‑DOSE (67457‑513‑05)

Active Ingredients:

  • Dactinomycin

Dosage Strength:

  • .5 mg/mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 67457-928 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 39822-2100 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by X-gen Pharmaceuticals, Inc.
  • 42658-008 Dactinomycin .5 mg Intravenous Injection, Powder, Lyophilized, for Solution by Hisun Pharmaceuticals USA, Inc.
  • 55150-431 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Auromedics Pharma LLC
  • 55150-928 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Auromedics Pharma LLC
  • 66993-489 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Prasco Laboratories
  • 71288-129 Dactinomycin .5 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Meitheal Pharmaceuticals Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.