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NDC 50419-0348-13 Ultravist 370 mg/mL Details
Ultravist 370 mg/mL
Ultravist is a INTRA-ARTERIAL; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bayer HealthCare Pharmaceuticals Inc.. The primary component is IOPROMIDE.
Product Information
| NDC | 50419-0348 |
|---|---|
| Product ID | 50419-348_dc7d3ecf-fbd3-4a06-878b-88e5b36441fc |
| Associated GPIs | 94402049002040 |
| GCN Sequence Number | 023254 |
| GCN Sequence Number Description | iopromide VIAL 370 MG/ML INJECTION |
| HIC3 | A6U |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS-RADIOPAQUE |
| GCN | 20992 |
| HICL Sequence Number | 009804 |
| HICL Sequence Number Description | IOPROMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Ultravist |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | iopromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRA-ARTERIAL; INTRAVENOUS |
| Active Ingredient Strength | 370 |
| Active Ingredient Units | mg/mL |
| Substance Name | IOPROMIDE |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50419-0348-13 (50419034813)
| NDC Package Code | 50419-348-13 |
|---|---|
| Billing NDC | 50419034813 |
| Package | 10 VIAL, GLASS in 1 CARTON (50419-348-13) / 100 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2022-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |