65219-088 : Gadoterate Meglumine 376.9 mg/ml Intravenous Injection


NDC: 65219-088
Labeler: Fresenius Kabi USA, LLC
Product Type: Human Prescription Drug
Drug Name:  Gadoterate Meglumine
Dosage Form: Intravenous Injection
Application #: ANDA215982
Rev. Date: 


NDC Package Codes:

  • 65219-088-50: 6 CARTON IN 1 BOX (65219‑088‑50) > 1 VIAL IN 1 CARTON (65219‑088‑06) > 100 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.
  • 65219-080 Gadoterate Meglumine 376.9 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
  • 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

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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.