NDC 69076-611

Riluzole

Riluzole

Riluzole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Quinn Pharmaceuticals, Llc. The primary component is Riluzole.

Product ID69076-611_d58c2bdc-ee77-4976-833d-0eff4cf78b79
NDC69076-611
Product TypeHuman Prescription Drug
Proprietary NameRiluzole
Generic NameRiluzole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA204430
Labeler NameQuinn Pharmaceuticals, Llc
Substance NameRILUZOLE
Active Ingredient Strength50 mg/1
Pharm ClassesBenzothiazole [EPC],Benzothiazoles [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69076-611-60

60 TABLET in 1 BOTTLE (69076-611-60)
Marketing Start Date2019-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69076-611-60 [69076061160]

Riluzole TABLET
Marketing CategoryANDA
Application NumberANDA204430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RILUZOLE50 mg/1

OpenFDA Data

SPL SET ID:d58c2bdc-ee77-4976-833d-0eff4cf78b79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199206
  • UPC Code
  • 0369076611603
  • Pharmacological Class

    • Benzothiazole [EPC]
    • Benzothiazoles [CS]

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

    NDCBrand NameGeneric Name
    0378-4145Riluzoleriluzole
    42291-775Riluzoleriluzole
    60505-3285RILUZOLERILUZOLE
    62756-538RiluzoleRiluzole
    64980-191Riluzoleriluzole
    67877-286RiluzoleRiluzole
    68084-908RILUZOLERILUZOLE
    68462-381riluzoleriluzole
    69076-200Riluzoleriluzole
    69076-611RiluzoleRiluzole
    10094-350EXSERVANriluzole
    70510-2201Exservanriluzole
    70510-2202Exservanriluzole
    70515-700Rilutekriluzole
    70726-0303TIGLUTIKRiluzole

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