NDC 70510-2171

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: 70510-2171_26a8730f-518e-40d1-b695-536526c6a87b
• NDC: 70510-2171
• Product Type: Human Prescription Drug
• Proprietary Name: RADICAVA
• Generic Name: Edaravone
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-05-05
• Marketing Category: NDA / NDA
• Application Number: NDA209176
• Labeler Name: Mitsubishi Tanabe Pharma America, Inc.
• Substance Name: EDARAVONE
• Active Ingredient Strength: 30 mg/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 70510-2171-2

2 BAG in 1 CARTON (70510-2171-2) > 100 mL in 1 BAG (70510-2171-1)

• Marketing Start Date: 2017-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70510-2171-2 [70510217102]

RADICAVA INJECTION

• Marketing Category: NDA
• Application Number: NDA209176
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-05
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-12

NDC 70510-2171-1 [70510217101]

RADICAVA INJECTION

• Marketing Category: NDA
• Application Number: NDA209176
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-05

NDC 70510-2171-0 [70510217100]

RADICAVA INJECTION

• Marketing Category: NDA
• Application Number: NDA209176
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-05
• Marketing End Date: 2017-11-14

Drug Details

Active Ingredients

Ingredient	Strength
EDARAVONE	30 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