NDC 65219-281 – Gadobutrol
Gadobutrol 604.72 mg/mL · Injection · Intravenous
Product NDC65219-281
Product details
- Brand name
- Gadobutrol
- Generic name
- Gadobutrol
- Labeler
- Fresenius Kabi USA, LLC
- Dosage form
- Injection
- Route
- Intravenous
- Marketing category
- ANDA · ANDA215061
- Marketed since
- April 14, 2023
- Listing expires
- December 31, 2026
- Pharmacologic class
- Gadolinium-based Contrast Agent
Active ingredients
- Gadobutrol 604.72 mg/mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 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) | Apr 14, 2023 |
| 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) | Apr 14, 2023 |
| 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) | Apr 14, 2023 |
| 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) | Apr 14, 2023 |
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