NDC 67684-2000
DOTAREM
Gadoterate Meglumine
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 |
Packaging
NDC 67684-2000-0
10 VIAL in 1 PACKAGE (67684-2000-0) > 5 mL in 1 VIAL
| Marketing Start Date | 2017-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 67684-2000-2 [67684200002]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-4 [67684200004]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-04-26 |
NDC 67684-2000-7 [67684200007]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-3 [67684200003]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-5 [67684200005]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-6 [67684200006]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-1 [67684200001]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-03-20 |
NDC 67684-2000-0 [67684200000]
DOTAREM INJECTION
| Marketing Category | NDA |
| Application Number | NDA204781 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-03-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOTERATE MEGLUMINE | 376.9 mg/mL |
OpenFDA Data
| SPL SET ID: | e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc |
| Manufacturer | |
| UNII | |
| UPC Code |
Pharmacological Class
- Gadolinium-based Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
NDC Crossover Matching brand name "DOTAREM" or generic name "Gadoterate Meglumine"
| 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 |
Trademark Results [DOTAREM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOTAREM 74328324 1818702 Live/Registered |
GUERBET 1992-11-05 |
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