NDC 50419-325 – Gadavist
Gadobutrol 604.72 mg/mL · Injection · Intravenous
Product NDC50419-325
Product details
- Brand name
- Gadavist
- Generic name
- gadobutrol
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Dosage form
- Injection
- Route
- Intravenous
- Marketing category
- NDA · NDA201277
- Marketed since
- March 14, 2011
- Listing expires
- December 31, 2027
- Pharmacologic class
- Gadolinium-based Contrast Agent
Active ingredients
- Gadobutrol 604.72 mg/mL
Package NDC codes (13)
| Package NDC | Description | Since |
|---|---|---|
| 50419-325-11 | 2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE | Mar 15, 2011 |
| 50419-325-12 | 2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE | Mar 15, 2011 |
| 50419-325-13 | 2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE | Mar 15, 2011 |
| 50419-325-18 | 2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS | Mar 15, 2011 |
| 50419-325-19 | 10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS | Mar 15, 2011 |
| 50419-325-27 | 5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS | Mar 15, 2011 |
| 50419-325-28 | 5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS | Mar 15, 2011 |
| 50419-325-29 | 5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS | Mar 15, 2011 |
| 50419-325-37 | 15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE | Mar 15, 2011 |
| 50419-325-72 sample | 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE | Mar 15, 2011 |
| 50419-325-73 | 30 mL in 1 BOTTLE, GLASS (50419-325-73) | Feb 11, 2021 |
| 50419-325-74 | 65 mL in 1 BOTTLE, GLASS (50419-325-74) | Feb 11, 2021 |
| 50419-325-75 sample | 5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS | May 12, 2022 |