riluzole

Generic: riluzole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name riluzole
Generic Name riluzole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

riluzole 50 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-381
Product ID 68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091394
Listing Expiration 2026-12-31
Marketing Start 2013-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462381
Hyphenated Format 68462-381

Supplemental Identifiers

RxCUI
199206
UPC
0368462381601
UNII
7LJ087RS6F
NUI
N0000175740 M0483511

Packaging Origin

Original Packager
true

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 ANDA091394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)
source: ndc

Packages (2)

68462-381-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10) 68462-381-60 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)

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": "e8a81e60-47b6-4097-9e49-48eb88e694f6", "openfda": {"nui": ["N0000175740", "M0483511"], "upc": ["0368462381601"], "unii": ["7LJ087RS6F"], "rxcui": ["199206"], "spl_set_id": ["f1ce57e8-d3fe-422c-8724-3101c258898a"], "pharm_class_cs": ["Benzothiazoles [CS]"], "pharm_class_epc": ["Benzothiazole [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10)", "package_ndc": "68462-381-10", "marketing_start_date": "20130618"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60)", "package_ndc": "68462-381-60", "marketing_start_date": "20130618"}], "brand_name": "riluzole", "product_id": "68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Benzothiazole [EPC]", "Benzothiazoles [CS]"], "product_ndc": "68462-381", "generic_name": "riluzole", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "riluzole", "active_ingredients": [{"name": "RILUZOLE", "strength": "50 mg/1"}], "application_number": "ANDA091394", "marketing_category": "ANDA", "marketing_start_date": "20130618", "listing_expiration_date": "20261231"}