NDC 0270-0083
Choletec
Mebrofenin
Choletec is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Mebrofenin.
| Product ID | 0270-0083_976ddf5c-e1a7-5bff-1af0-4d85c2bb50e7 |
| NDC | 0270-0083 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Choletec |
| Generic Name | Mebrofenin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 1987-01-21 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018963 |
| Labeler Name | Bracco Diagnostics Inc |
| Substance Name | MEBROFENIN |
| Active Ingredient Strength | 45 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0270-0083-20
10 VIAL in 1 CARTON (0270-0083-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
| Marketing Start Date | 1987-01-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0270-0083-20 [00270008320]
Choletec INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018963 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1987-01-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MEBROFENIN | 45 mg/1 |
OpenFDA Data
| SPL SET ID: | fd085485-998d-42a3-879a-b2d96cb8aed7 |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "Choletec" or generic name "Mebrofenin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0270-0083 | Choletec | Mebrofenin |
| 51808-216 | Mebrofenin | Mebrofenin |
Trademark Results [Choletec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHOLETEC 73352605 1255776 Live/Registered |
E. R. Squibb & Sons, Inc. 1982-03-01 |
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