NDC 0270-1111
ProHance
Gadoteridol
ProHance is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Gadoteridol.
| Product ID | 0270-1111_09633ce5-0c24-479c-bc6d-4a7138abc1f2 |
| NDC | 0270-1111 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ProHance |
| Generic Name | Gadoteridol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 1992-11-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020131 |
| Labeler Name | BRACCO DIAGNOSTICS INC |
| Substance Name | GADOTERIDOL |
| Active Ingredient Strength | 279 mg/mL |
| Pharm Classes | Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0270-1111-01
5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) > 10 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 1992-11-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0270-1111-70 [00270111170]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA021489 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-10-09 |
NDC 0270-1111-45 [00270111145]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
NDC 0270-1111-01 [00270111101]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
NDC 0270-1111-04 [00270111104]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
NDC 0270-1111-16 [00270111116]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
NDC 0270-1111-02 [00270111102]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
NDC 0270-1111-03 [00270111103]
ProHance INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020131 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1992-11-16 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOTERIDOL | 279.3 mg/mL |
OpenFDA Data
| SPL SET ID: | 778aee03-7d4c-481a-be8a-a75db0702f5a |
| Manufacturer | |
| UNII |
Pharmacological Class
- Magnetic Resonance Contrast Activity [MoA]
- Paramagnetic Contrast Agent [EPC]
Trademark Results [ProHance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROHANCE 97264281 not registered Live/Pending |
JAMOCHA TECH PRIVATE LIMITED 2022-02-11 |
 PROHANCE 97182054 not registered Live/Pending |
JAMOCHA TECH PRIVATE LIMITED 2021-12-21 |
 PROHANCE 75572308 not registered Dead/Abandoned |
United Agri Products 1998-10-19 |
 PROHANCE 74392033 1820972 Live/Registered |
BRACCO DIAGNOSTICS INC. 1993-05-19 |
 PROHANCE 74222866 not registered Dead/Abandoned |
E. R. Squibb & Sons, Inc. 1991-11-14 |
 PROHANCE 74032581 not registered Dead/Abandoned |
E. R. Squibb & Sons, Inc. 1990-02-26 |
 PROHANCE 73809193 1582205 Live/Registered |
E. R. SQUIBB & SONS, INC. 1989-06-26 |
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