NDC 0407-2943

CLARISCAN

Gadoterate Meglumine

CLARISCAN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare. The primary component is Gadoterate Meglumine.

• Product ID: 0407-2943_05dd928c-a19a-4836-bc67-6986b965c23f
• NDC: 0407-2943
• Product Type: Human Prescription Drug
• Proprietary Name: CLARISCAN
• Generic Name: Gadoterate Meglumine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210016
• Labeler Name: GE Healthcare
• 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 0407-2943-70

10 BOTTLE, PLASTIC in 1 BOX (0407-2943-70) > 100 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2020-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0407-2943-01 [00407294301]

CLARISCAN INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210016
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-01

NDC 0407-2943-02 [00407294302]

CLARISCAN INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210016
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-01

NDC 0407-2943-05 [00407294305]

CLARISCAN INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA210016
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-01

Drug Details

Active Ingredients

Ingredient	Strength
GADOTERATE MEGLUMINE	376.9 mg/mL

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0407-2943	CLARISCAN	gadoterate meglumine
67684-2000	DOTAREM	gadoterate meglumine
67684-2001	DOTAREM	gadoterate meglumine
67684-3001	DOTAREM	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