65219-080 : Gadoterate Meglumine 376.9 mg/ml Intravenous Injection


NDC: 65219-080
Labeler: Fresenius Kabi USA, LLC
Product Type: Human Prescription Drug
Drug Name:  Gadoterate Meglumine
Dosage Form: Intravenous Injection
Application #: ANDA215304
Rev. Date: 


NDC Package Codes:

  • 65219-080-05: 10 CARTON IN 1 BOX (65219‑080‑05) > 1 VIAL IN 1 CARTON (65219‑080‑01) > 5 ML IN 1 VIAL

Active Ingredients:

  • Gadoterate Meglumine

Dosage Strength:

  • 376.9 mg/mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 65219-082 Gadoterate Meglumine 376.9 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
  • 65219-084 Gadoterate Meglumine 376.9 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
  • 65219-086 Gadoterate Meglumine 376.9 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
  • 65219-088 Gadoterate Meglumine 376.9 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC

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