NDC 70515-700

Rilutek

Riluzole

Rilutek is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Covis Pharma. The primary component is Riluzole.

• Product ID: 70515-700_6ddc26d7-a6fe-46dd-8b49-c55aa111f83e
• NDC: 70515-700
• Product Type: Human Prescription Drug
• Proprietary Name: Rilutek
• Generic Name: Riluzole
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA020599
• Labeler Name: Covis Pharma
• Substance Name: RILUZOLE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Benzothiazole [EPC],Benzothiazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70515-700-60

1 BOTTLE in 1 CARTON (70515-700-60) > 60 TABLET in 1 BOTTLE

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70515-700-60 [70515070060]

Rilutek TABLET

• Marketing Category: NDA
• Application Number: NDA020599
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-01

Drug Details

Active Ingredients

Ingredient	Strength
RILUZOLE	50 mg/1

OpenFDA Data

• SPL SET ID: 6ddc26d7-a6fe-46dd-8b49-c55aa111f83e
• Manufacturer:
  • Covis Pharma
• UNII:
  • 7LJ087RS6F
• RxNorm Concept Unique ID - RxCUI:
  • 152915
  • 199206
• UPC Code:
  • 0370515700604

Pharmacological Class

• Benzothiazole [EPC]
• Benzothiazoles [CS]

NDC Crossover Matching brand name "Rilutek" or generic name "Riluzole"

NDC	Brand Name	Generic Name
70515-700	Rilutek	riluzole
10094-350	EXSERVAN	riluzole
70510-2201	Exservan	riluzole
70510-2202	Exservan	riluzole
0378-4145	Riluzole	riluzole
42291-775	Riluzole	riluzole
60505-3285	RILUZOLE	RILUZOLE
62756-538	Riluzole	Riluzole
64980-191	Riluzole	riluzole
67877-286	Riluzole	Riluzole
68084-908	RILUZOLE	RILUZOLE
68462-381	riluzole	riluzole
69076-200	Riluzole	riluzole
69076-611	Riluzole	Riluzole
70726-0303	TIGLUTIK	Riluzole