riluzole

Generic: riluzole

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name riluzole
Generic Name riluzole
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

riluzole 50 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-775
Product ID 42291-775_4c362542-247a-50f1-e063-6394a90a5065
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206045
Listing Expiration 2027-12-31
Marketing Start 2020-10-07

Pharmacologic Class

Established (EPC)
benzothiazole [epc]
Chemical Structure
benzothiazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291775
Hyphenated Format 42291-775

Supplemental Identifiers

RxCUI
199206
UPC
0342291775602
UNII
7LJ087RS6F
NUI
N0000175740 M0483511

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name riluzole (source: ndc)
Generic Name riluzole (source: ndc)
Application Number ANDA206045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)
source: ndc

Packages (1)

42291-775-60 60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)

Ingredients (1)

riluzole (50 mg/1)

Linked Drug Pages (1)

Riluzole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c362542-247a-50f1-e063-6394a90a5065", "openfda": {"nui": ["N0000175740", "M0483511"], "upc": ["0342291775602"], "unii": ["7LJ087RS6F"], "rxcui": ["199206"], "spl_set_id": ["b117b981-476c-f9b8-e053-2995a90aee5f"], "pharm_class_cs": ["Benzothiazoles [CS]"], "pharm_class_epc": ["Benzothiazole [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)", "package_ndc": "42291-775-60", "marketing_start_date": "20201007"}], "brand_name": "Riluzole", "product_id": "42291-775_4c362542-247a-50f1-e063-6394a90a5065", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Benzothiazole [EPC]", "Benzothiazoles [CS]"], "product_ndc": "42291-775", "generic_name": "riluzole", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Riluzole", "active_ingredients": [{"name": "RILUZOLE", "strength": "50 mg/1"}], "application_number": "ANDA206045", "marketing_category": "ANDA", "marketing_start_date": "20201007", "listing_expiration_date": "20271231"}