NDC 0270-1316
ISOVUE 370
Iopamidol
ISOVUE 370 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 | 0270-1316_01b4c288-3a85-406e-9c0a-bc801f85ed52 |
| NDC | 0270-1316 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ISOVUE 370 |
| 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 | 755 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 0270-1316-45
10 BOTTLE in 1 BOX (0270-1316-45) > 200 mL in 1 BOTTLE
| Marketing Start Date | 2014-06-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0270-1316-47 [00270131647]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-31 |
| Marketing End Date | 2011-09-29 |
NDC 0270-1316-52 [00270131652]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1316-44 [00270131644]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-31 |
| Marketing End Date | 2011-09-29 |
NDC 0270-1316-45 [00270131645]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-20 |
NDC 0270-1316-95 [00270131695]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-20 |
NDC 0270-1316-01 [00270131601]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
| Marketing End Date | 2016-12-31 |
NDC 0270-1316-40 [00270131640]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-31 |
| Marketing End Date | 2011-09-29 |
NDC 0270-1316-04 [00270131604]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1316-98 [00270131698]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1994-10-12 |
NDC 0270-1316-35 [00270131635]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1316-37 [00270131637]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1316-41 [00270131641]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020327 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1994-10-12 |
NDC 0270-1316-30 [00270131630]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-31 |
NDC 0270-1316-07 [00270131607]
ISOVUE 370 INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018735 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-31 |
| Marketing End Date | 2011-09-29 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOPAMIDOL | 755 mg/mL |
OpenFDA Data
| SPL SET ID: | 797a11d7-dcd4-43ff-311b-3b48a10da2f2 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "ISOVUE 370" or generic name "Iopamidol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 76381-316 | ISOVUE 370 | ISOVUE 370 |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.