NDC 10094-350

EXSERVAN

Riluzole

EXSERVAN is a Oral Film in the Human Prescription Drug category. It is labeled and distributed by Aquestive Therapeutics. The primary component is Riluzole.

• Product ID: 10094-350_2214fe05-3eae-4b7e-b9d9-70c388ae7500
• NDC: 10094-350
• Product Type: Human Prescription Drug
• Proprietary Name: EXSERVAN
• Generic Name: Riluzole
• Dosage Form: Film
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-24
• Marketing Category: NDA / NDA
• Application Number: NDA212640
• Labeler Name: Aquestive Therapeutics
• Substance Name: RILUZOLE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Benzothiazole [EPC],Benzothiazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 10094-350-60

50 POUCH in 1 CARTON (10094-350-60) > 1 FILM in 1 POUCH

• Marketing Start Date: 2019-01-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10094-350-60 [10094035060]

EXSERVAN FILM

• Marketing Category: NDA
• Application Number: NDA212640
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-24

Drug Details

Active Ingredients

Ingredient	Strength
RILUZOLE	50 mg/1

OpenFDA Data

• SPL SET ID: 0a4ad0db-ce67-4724-91d2-88258c2cc9f8
• Manufacturer:
  • Aquestive Therapeutics
• UNII:
  • 7LJ087RS6F
• RxNorm Concept Unique ID - RxCUI:
  • 2265862
  • 2267572

Pharmacological Class

• Benzothiazole [EPC]
• Benzothiazoles [CS]

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

NDC	Brand Name	Generic Name
10094-350	EXSERVAN	riluzole
70510-2201	Exservan	riluzole
70510-2202	Exservan	riluzole
70515-700	Rilutek	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