NDC 67684-2001

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 ID67684-2001_2b0867d4-7c5c-4601-a832-c03ca32d7e39
NDC67684-2001
Product TypeHuman Prescription Drug
Proprietary NameDOTAREM
Generic NameGadoterate Meglumine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-03-20
Marketing CategoryNDA / NDA
Application NumberNDA204781
Labeler NameGuerbet LLC
Substance NameGADOTERATE MEGLUMINE
Active Ingredient Strength377 mg/mL
Pharm ClassesGadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67684-2001-0

10 VIAL in 1 PACKAGE (67684-2001-0) > 5 mL in 1 VIAL
Marketing Start Date2019-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67684-2001-4 [67684200104]

DOTAREM INJECTION
Marketing CategoryNDA
Application NumberNDA204781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-04-26

NDC 67684-2001-1 [67684200101]

DOTAREM INJECTION
Marketing CategoryNDA
Application NumberNDA204781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-24

NDC 67684-2001-0 [67684200100]

DOTAREM INJECTION
Marketing CategoryNDA
Application NumberNDA204781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-24

NDC 67684-2001-3 [67684200103]

DOTAREM INJECTION
Marketing CategoryNDA
Application NumberNDA204781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-24

NDC 67684-2001-2 [67684200102]

DOTAREM INJECTION
Marketing CategoryNDA
Application NumberNDA204781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-24

Drug Details

Active Ingredients

IngredientStrength
GADOTERATE MEGLUMINE376.9 mg/mL

Pharmacological Class

  • Gadolinium-based Contrast Agent [EPC]
  • Magnetic Resonance Contrast Activity [MoA]

NDC Crossover Matching brand name "DOTAREM" or generic name "Gadoterate Meglumine"

NDCBrand NameGeneric Name
67684-2000DOTAREMgadoterate meglumine
67684-2001DOTAREMgadoterate meglumine
67684-3001DOTAREMgadoterate meglumine
0407-2943CLARISCANgadoterate meglumine
65219-080Gadoterate Megluminegadoterate meglumine
65219-082Gadoterate Megluminegadoterate meglumine
65219-084Gadoterate Megluminegadoterate meglumine
65219-086Gadoterate Megluminegadoterate meglumine
65219-088Gadoterate Megluminegadoterate meglumine

Trademark Results [DOTAREM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DOTAREM
DOTAREM
74328324 1818702 Live/Registered
GUERBET
1992-11-05

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