NDC 50419-346
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 | 50419-346_1082cd73-403a-4109-a036-25097e2064c1 |
| NDC | 50419-346 |
| 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 | 370 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 50419-346-05
10 VIAL, GLASS in 1 CARTON (50419-346-05) > 50 mL in 1 VIAL, GLASS
| Marketing Start Date | 2009-12-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-346-97 [50419034697]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-10-11 |
NDC 50419-346-58 [50419034658]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-12 [50419034612]
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 | 2017-07-27 |
NDC 50419-346-65 [50419034665]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-05-04 |
NDC 50419-346-25 [50419034625]
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 | 2016-11-28 |
NDC 50419-346-26 [50419034626]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-07 [50419034607]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-20 [50419034620]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-05 [50419034605]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-41 [50419034641]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-10 [50419034610]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-45 [50419034645]
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 50419-346-43 [50419034643]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-48 [50419034648]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-12-30 |
| Marketing End Date | 2016-11-28 |
NDC 50419-346-15 [50419034615]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-12-30 |
NDC 50419-346-28 [50419034628]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-05-04 |
NDC 50419-346-50 [50419034650]
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 | 2010-05-05 |
NDC 50419-346-33 [50419034633]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-11-28 |
NDC 50419-346-91 [50419034691]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA020220 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-10-11 |
NDC 50419-346-32 [50419034632]
Ultravist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021425 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-11-28 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOPROMIDE | 370 mg/mL |
OpenFDA Data
| SPL SET ID: | 65647318-27e4-4f37-bd68-50eea52d6c5b |
| 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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