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DOTAREM
DOTAREM - 67684-2000-1 - (gadoterate meglumine)
Drug Information of DOTAREM
| Product NDC: | 67684-2000 |
| Proprietary Name: | DOTAREM |
| Non Proprietary Name: | gadoterate meglumine |
| Active Ingredient(s): | 376.9 mg/mL & nbsp; gadoterate meglumine |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of DOTAREM
| Product NDC: | 67684-2000 |
| Labeler Name: | Guerbet LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA204781 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130320 |
Package Information of DOTAREM
| Package NDC: | 67684-2000-1 |
| Package Description: | 10 VIAL in 1 PACKAGE (67684-2000-1) > 10 mL in 1 VIAL |
NDC Information of DOTAREM
| NDC Code | 67684-2000-1 |
| Proprietary Name | DOTAREM |
| Package Description | 10 VIAL in 1 PACKAGE (67684-2000-1) > 10 mL in 1 VIAL |
| Product NDC | 67684-2000 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | gadoterate meglumine |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130320 |
| Marketing Category Name | NDA |
| Labeler Name | Guerbet LLC |
| Substance Name | GADOTERATE MEGLUMINE |
| Strength Number | 376.9 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |
