NDC 0270-1315
ISOVUE 300
Iopamidol
ISOVUE 300 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Iopamidol.
| Product ID | 0270-1315_01b4c288-3a85-406e-9c0a-bc801f85ed52 |
| NDC | 0270-1315 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ISOVUE 300 |
| Generic Name | Iopamidol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2014-06-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020327 |
| Labeler Name | Bracco Diagnostics Inc |
| Substance Name | IOPAMIDOL |
| Active Ingredient Strength | 612 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0270-1315-45
10 BOTTLE in 1 BOX (0270-1315-45) > 200 mL in 1 BOTTLE
| Marketing Start Date | 2014-06-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0270-1315-50 [00270131550]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1315-41 [00270131541]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1994-10-12 |
NDC 0270-1315-25 [00270131525]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1315-45 [00270131545]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-20 |
NDC 0270-1315-35 [00270131535]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1315-47 [00270131547]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1315-95 [00270131595]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-20 |
NDC 0270-1315-98 [00270131598]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1994-10-12 |
NDC 0270-1315-30 [00270131530]
ISOVUE 300 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOPAMIDOL | 612 mg/mL |
OpenFDA Data
| SPL SET ID: | 416ab996-a2e8-4fe1-a9c9-f10b86df3bb5 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "ISOVUE 300" or generic name "Iopamidol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 76381-315 | ISOVUE 300 | ISOVUE 300 |
| 0270-1314 | ISOVUE | IOPAMIDOL |
| 0270-1315 | ISOVUE | IOPAMIDOL |
| 0270-1316 | ISOVUE | IOPAMIDOL |
| 0270-1317 | ISOVUE | IOPAMIDOL |
Trademark Results [ISOVUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOVUE 85423219 4243227 Dead/Cancelled |
Centrix, Inc. 2011-09-15 |
 ISOVUE 75239760 2132582 Dead/Cancelled |
BRACCO DIAGNOSTICS, INC. 1997-02-07 |
 ISOVUE 73299442 1237972 Live/Registered |
E. R. Squibb & Sons, Inc. 1981-02-25 |
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