NDC 70510-2172

RADICAVA

Edaravone

RADICAVA is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Mitsubishi Tanabe Pharma America, Inc.. The primary component is Edaravone.

• Product ID: 70510-2172_df6522ed-2347-488b-8f75-9ec8e60ca28a
• NDC: 70510-2172
• Product Type: Human Prescription Drug
• Proprietary Name: RADICAVA
• Generic Name: Edaravone
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-05-05
• Marketing Category: NDA / NDA
• Application Number: NDA209176
• Labeler Name: Mitsubishi Tanabe Pharma America, Inc.
• Substance Name: EDARAVONE
• Active Ingredient Strength: 60 mg/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70510-2172-1

2 BAG in 1 CARTON (70510-2172-1) > 100 mL in 1 BAG (70510-2172-0)

• Marketing Start Date: 2020-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70510-2172-1 [70510217201]

RADICAVA INJECTION

• Marketing Category: NDA
• Application Number: NDA209176
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-05

NDC 70510-2172-0 [70510217200]

RADICAVA INJECTION

• Marketing Category: NDA
• Application Number: NDA209176
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-05-05

Drug Details

Active Ingredients

Ingredient	Strength
EDARAVONE	60 mg/100mL

NDC Crossover Matching brand name "RADICAVA" or generic name "Edaravone"

NDC	Brand Name	Generic Name
70510-2171	RADICAVA	EDARAVONE
70510-2172	RADICAVA	edaravone
70510-2321	RADICAVA ORS	EDARAVONE
70510-2322	RADICAVA ORS	EDARAVONE