NDC 50419-342
Ultravist
Iopromide
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 ID | 50419-342_6eaf4f32-0202-48fd-b09c-910ad157298a |
| NDC | 50419-342 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ultravist |
| Generic Name | Iopromide |
| Dosage Form | Injection |
| Route of Administration | INTRA-ARTERIAL; INTRAVENOUS |
| Marketing Start Date | 2009-12-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020220 |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | IOPROMIDE |
| Active Ingredient Strength | 240 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 50419-342-21
10 BOTTLE in 1 PACKAGE (50419-342-21) > 200 mL in 1 BOTTLE
| Marketing Start Date | 2009-12-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-342-05 [50419034205]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2021-01-03 |
NDC 50419-342-15 [50419034215]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2010-05-05 |
NDC 50419-342-41 [50419034241]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2017-07-27 |
NDC 50419-342-43 [50419034243]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2017-07-27 |
NDC 50419-342-21 [50419034221]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2020-04-30 |
NDC 50419-342-10 [50419034210]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2021-01-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOPROMIDE | 240 mg/mL |
OpenFDA Data
| SPL SET ID: | d96a7883-d160-40a1-bdbd-2e8d7877cd18 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "Ultravist" or generic name "Iopromide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50419-342 | Ultravist | iopromide |
| 50419-344 | Ultravist | iopromide |
| 50419-346 | Ultravist | iopromide |
Trademark Results [Ultravist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRAVIST 73708062 1542191 Live/Registered |
SCHERING AG, BERLIN AND BERGKAMEN 1988-03-10 |
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