65219-281 : Gadobutrol 604.72 mg/ml Intravenous Injection
| NDC: | 65219-281 |
| Labeler: | Fresenius Kabi USA, LLC |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Gadobutrol |
| Dosage Form: | Intravenous Injection |
| Application #: | ANDA215061 |
| Rev. Date: |
NDC Package Codes:
- 65219-281-02: 5 CARTON IN 1 BOX (65219‑281‑02) / 3 VIAL, SINGLE‑DOSE IN 1 CARTON / 2 ML IN 1 VIAL, SINGLE‑DOSE (65219‑281‑00)
- 65219-281-07: 2 CARTON IN 1 BOX (65219‑281‑07) / 10 VIAL, SINGLE‑DOSE IN 1 CARTON / 7.5 ML IN 1 VIAL, SINGLE‑DOSE (65219‑281‑03)
- 65219-281-10: 2 CARTON IN 1 BOX (65219‑281‑10) / 10 VIAL, SINGLE‑DOSE IN 1 CARTON / 10 ML IN 1 VIAL, SINGLE‑DOSE (65219‑281‑08)
- 65219-281-15: 2 CARTON IN 1 BOX (65219‑281‑15) / 10 VIAL, SINGLE‑DOSE IN 1 CARTON / 15 ML IN 1 VIAL, SINGLE‑DOSE (65219‑281‑05)
Active Ingredients:
- Gadobutrol
Dosage Strength:
- 604.72 mg/mL
Pharmaceutical Classes:
- Gadolinium-based Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
Related Products:
Based on records with the same trade name.- 65219-287 Gadobutrol 604.72 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
- 65219-289 Gadobutrol 604.72 mg/ml Intravenous Injection by Fresenius Kabi USA, LLC
- 70436-122 Gadobutrol 604.72 mg/ml Intravenous Injection by Slate Run Pharmaceuticals, LLC
- 70436-212 Gadobutrol 604.72 mg/ml Intravenous Injection by Slate Run Pharmaceuticals, LLC
- 70436-214 Gadobutrol 604.72 mg/ml Intravenous Injection by Slate Run Pharmaceuticals, 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.