DOTAREM is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Guerbet Llc. The primary component is Gadoterate Meglumine.
Product ID | 67684-2000_2b0867d4-7c5c-4601-a832-c03ca32d7e39 |
NDC | 67684-2000 |
Product Type | Human Prescription Drug |
Proprietary Name | DOTAREM |
Generic Name | Gadoterate Meglumine |
Dosage Form | Injection |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA / NDA |
Application Number | NDA204781 |
Labeler Name | Guerbet LLC |
Substance Name | GADOTERATE MEGLUMINE |
Active Ingredient Strength | 377 mg/mL |
Pharm Classes | Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2017-03-31 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-04-26 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-03-20 |
Marketing Category | NDA |
Application Number | NDA204781 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2017-03-31 |
Ingredient | Strength |
---|---|
GADOTERATE MEGLUMINE | 376.9 mg/mL |
SPL SET ID: | e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc |
Manufacturer | |
UNII | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
67684-2000 | DOTAREM | gadoterate meglumine |
67684-2001 | DOTAREM | gadoterate meglumine |
67684-3001 | DOTAREM | gadoterate meglumine |
0407-2943 | CLARISCAN | gadoterate meglumine |
65219-080 | Gadoterate Meglumine | gadoterate meglumine |
65219-082 | Gadoterate Meglumine | gadoterate meglumine |
65219-084 | Gadoterate Meglumine | gadoterate meglumine |
65219-086 | Gadoterate Meglumine | gadoterate meglumine |
65219-088 | Gadoterate Meglumine | gadoterate meglumine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DOTAREM 74328324 1818702 Live/Registered |
GUERBET 1992-11-05 |