NDC 70726-0303

TIGLUTIK

Riluzole

TIGLUTIK is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Itf Pharma, Inc.. The primary component is Riluzole.

• Product ID: 70726-0303_67b29266-d9a4-4a83-8f07-f41ec96cb341
• NDC: 70726-0303
• Product Type: Human Prescription Drug
• Proprietary Name: TIGLUTIK
• Generic Name: Riluzole
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-21
• Marketing Category: NDA / NDA
• Application Number: NDA209080
• Labeler Name: Itf Pharma, Inc.
• Substance Name: RILUZOLE
• Active Ingredient Strength: 50 mg/10mL
• Pharm Classes: Benzothiazole [EPC],Benzothiazoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70726-0303-2

2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-2) > 300 mL in 1 BOTTLE, PLASTIC (70726-0303-1)

• Marketing Start Date: 2018-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70726-0303-2 [70726030302]

TIGLUTIK LIQUID

• Marketing Category: NDA
• Application Number: NDA209080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-21
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-12

NDC 70726-0303-1 [70726030301]

TIGLUTIK LIQUID

• Marketing Category: NDA
• Application Number: NDA209080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-21

Drug Details

Active Ingredients

Ingredient	Strength
RILUZOLE	50 mg/10mL

OpenFDA Data

• SPL SET ID: 75d68f19-4208-109e-e053-2991aa0ac857
• Manufacturer:
  • Itf Pharma, Inc.
• UNII:
  • 7LJ087RS6F
• RxNorm Concept Unique ID - RxCUI:
  • 2058147
  • 2059266
• UPC Code:
  • 0370726030323

Pharmacological Class

• Benzothiazole [EPC]
• Benzothiazoles [CS]

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

NDC	Brand Name	Generic Name
70726-0303	TIGLUTIK	Riluzole
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