NDC 0270-5164
MultiHance
Gadobenate Dimeglumine
MultiHance is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Gadobenate Dimeglumine.
| Product ID | 0270-5164_36dcd028-bb98-e874-5e66-55259a49697a |
| NDC | 0270-5164 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MultiHance |
| Generic Name | Gadobenate Dimeglumine |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2004-11-23 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021357 |
| Labeler Name | BRACCO DIAGNOSTICS INC |
| Substance Name | GADOBENATE DIMEGLUMINE |
| Active Ingredient Strength | 529 mg/mL |
| Pharm Classes | Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0270-5164-12
5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) > 5 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2004-11-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0270-5164-19 [00270516419]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-10 |
| Marketing End Date | 2012-12-31 |
NDC 0270-5164-20 [00270516420]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-10 |
| Marketing End Date | 2012-12-31 |
NDC 0270-5164-14 [00270516414]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-11-23 |
NDC 0270-5164-15 [00270516415]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-11-23 |
NDC 0270-5164-18 [00270516418]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-10 |
| Marketing End Date | 2012-12-31 |
NDC 0270-5164-13 [00270516413]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-11-23 |
NDC 0270-5164-12 [00270516412]
MultiHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021357 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-11-23 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOBENATE DIMEGLUMINE | 529 mg/mL |
OpenFDA Data
| SPL SET ID: | 59077a3e-5f03-4342-ae24-856267545631 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Gadolinium-based Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
NDC Crossover Matching brand name "MultiHance" or generic name "Gadobenate Dimeglumine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0270-5164 | MultiHance | gadobenate dimeglumine |
| 0270-5264 | MultiHance | gadobenate dimeglumine |
Trademark Results [MultiHance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTIHANCE 76615156 3061811 Live/Registered |
Bracco International B.V. 2004-10-08 |
 MULTIHANCE 75202806 2194677 Dead/Cancelled |
BRACCO INTERNATIONAL B.V. 1996-11-22 |
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