67684-2000 : Dotarem 376.9 mg/ml Intravenous Injection


NDC: 67684-2000
Labeler: Guerbet LLC
Product Type: Human Prescription Drug
Drug Name:  Dotarem
Dosage Form: Intravenous Injection
Application #: NDA204781
Rev. Date: 


NDC Package Codes:

  • 67684-2000-0: 10 VIAL IN 1 PACKAGE (67684‑2000‑0) > 5 ML IN 1 VIAL
  • 67684-2000-1: 10 VIAL IN 1 PACKAGE (67684‑2000‑1) > 10 ML IN 1 VIAL
  • 67684-2000-2: 10 VIAL IN 1 PACKAGE (67684‑2000‑2) > 15 ML IN 1 VIAL
  • 67684-2000-3: 10 VIAL IN 1 PACKAGE (67684‑2000‑3) > 20 ML IN 1 VIAL
  • 67684-2000-4: 6 VIAL IN 1 PACKAGE (67684‑2000‑4) > 100 ML IN 1 VIAL
  • 67684-2000-5: 5 SYRINGE IN 1 PACKAGE (67684‑2000‑5) > 10 ML IN 1 SYRINGE
  • 67684-2000-6: 5 SYRINGE IN 1 PACKAGE (67684‑2000‑6) > 15 ML IN 1 SYRINGE
  • 67684-2000-7: 5 SYRINGE IN 1 PACKAGE (67684‑2000‑7) > 20 ML IN 1 SYRINGE

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.
  • 67684-2001 Dotarem 376.9 mg/ml Intravenous Injection by Guerbet LLC
  • 67684-3001 Dotarem 376.9 mg/ml Intravenous Injection by Guerbet 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.