NDC 67684-3001

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: 67684-3001_2b0867d4-7c5c-4601-a832-c03ca32d7e39
• NDC: 67684-3001
• Product Type: Human Prescription Drug
• Proprietary Name: DOTAREM
• Generic Name: Gadoterate Meglumine
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-09-18
• 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 67684-3001-1

10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) > 10 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2019-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67684-3001-3 [67684300103]

DOTAREM INJECTION

• Marketing Category: NDA
• Application Number: NDA204781
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-18

NDC 67684-3001-1 [67684300101]

DOTAREM INJECTION

• Marketing Category: NDA
• Application Number: NDA204781
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-18

NDC 67684-3001-2 [67684300102]

DOTAREM INJECTION

• Marketing Category: NDA
• Application Number: NDA204781
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-18

Drug Details

Active Ingredients

Ingredient	Strength
GADOTERATE MEGLUMINE	376.9 mg/mL

OpenFDA Data

• SPL SET ID: e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc
• Manufacturer:
  • Guerbet LLC
• UNII:
  • L0ND3981AG
• UPC Code:
  • 0367684200011
  • 0367684300117

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