Ultravist
- Product NDC
- 50419-347
- 11-digit product format
- 504190347
- Labeler code
- 50419
- Product ID
- 50419-347_4314fa34-edbc-44f3-b40b-277c6fbd2ab0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iopromide
- Dosage form
- INJECTION
- Route
- INTRA-ARTERIAL; INTRAVENOUS
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA020220
- Marketing category
- NDA
- Marketing start
- 2022-06-08
- Substance
- IOPROMIDE
- Active strength
- 300 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 712BAC33MZ | IOPROMIDE | 73334-07-3 | IOPROMIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50419-347-05 | 50419034705 | 50 mL in 1 VIAL, GLASS (50419-347-05) | 50 ml | 2022-06-08 | No | No | Historical |
| 50419-347-20 | 50419034720 | 200 mL in 1 VIAL, GLASS (50419-347-20) | 200 ml | 2022-06-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ultravist | Bayer HealthCare Pharmaceuticals Inc. | Bayer AG | 2026-03-02 | HUMAN PRESCRIPTION DRUG LABEL | 25 |