50419-325 : Gadavist 604.72 mg/ml Intravenous Injection


NDC: 50419-325
Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Gadavist
Dosage Form: Intravenous Injection
Application #: NDA201277
Rev. Date: 


NDC Package Codes:

  • 50419-325-11: 2 CARTON IN 1 BOX (50419‑325‑11) > 10 VIAL, SINGLE‑DOSE IN 1 CARTON > 7.5 ML IN 1 VIAL, SINGLE‑DOSE
  • 50419-325-12: 2 CARTON IN 1 BOX (50419‑325‑12) > 10 VIAL, SINGLE‑DOSE IN 1 CARTON > 10 ML IN 1 VIAL, SINGLE‑DOSE
  • 50419-325-13: 2 CARTON IN 1 BOX (50419‑325‑13) > 10 VIAL, SINGLE‑DOSE IN 1 CARTON > 15 ML IN 1 VIAL, SINGLE‑DOSE
  • 50419-325-14: 2 CARTON IN 1 BOX (50419‑325‑14) > 5 BOTTLE, GLASS IN 1 CARTON > 30 ML IN 1 BOTTLE, GLASS
  • 50419-325-15: 10 BOTTLE, GLASS IN 1 BOX (50419‑325‑15) > 65 ML IN 1 BOTTLE, GLASS
  • 50419-325-18: 2 CARTON IN 1 BOX (50419‑325‑18) > 5 BOTTLE, GLASS IN 1 CARTON > 30 ML IN 1 BOTTLE, GLASS
  • 50419-325-19: 10 BOTTLE, GLASS IN 1 BOX (50419‑325‑19) > 65 ML IN 1 BOTTLE, GLASS
  • 50419-325-27: 5 SYRINGE, GLASS IN 1 BOX (50419‑325‑27) > 7.5 ML IN 1 SYRINGE, GLASS
  • 50419-325-28: 5 SYRINGE, GLASS IN 1 BOX (50419‑325‑28) > 10 ML IN 1 SYRINGE, GLASS
  • 50419-325-29: 5 SYRINGE, GLASS IN 1 BOX (50419‑325‑29) > 15 ML IN 1 SYRINGE, GLASS
  • 50419-325-37: 15 CARTON IN 1 BOX (50419‑325‑37) > 3 VIAL, SINGLE‑DOSE IN 1 CARTON > 2 ML IN 1 VIAL, SINGLE‑DOSE
  • 50419-325-72: 10 VIAL, SINGLE‑DOSE IN 1 CARTON (50419‑325‑72) > 10 ML IN 1 VIAL, SINGLE‑DOSE
  • 50419-325-73: 30 ML IN 1 BOTTLE, GLASS (50419‑325‑73)
  • 50419-325-74: 65 ML IN 1 BOTTLE, GLASS (50419‑325‑74)
  • 50419-325-75: 5 SYRINGE, GLASS IN 1 BOX (50419‑325‑75) > 10 ML IN 1 SYRINGE, GLASS

Active Ingredients:

  • Gadobutrol

Dosage Strength:

  • 604.72 mg/mL

Pharmaceutical Classes:

  • Gadolinium-based Contrast Agent [EPC]
  • Magnetic Resonance Contrast Activity [MoA]

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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.