riluzole

Generic: riluzole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name riluzole
Generic Name riluzole
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

riluzole 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-538
Product ID 62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091417
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 62756538
Hyphenated Format 62756-538

Supplemental Identifiers

RxCUI
199206
UPC
0362756538832
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 ANDA091417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83)
  • 60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86)
  • 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)
source: ndc

Packages (4)

62756-538-18 1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18) 62756-538-83 30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83) 62756-538-86 60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86) 62756-538-88 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)

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": "9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2", "openfda": {"nui": ["N0000175740", "M0483511"], "upc": ["0362756538832"], "unii": ["7LJ087RS6F"], "rxcui": ["199206"], "spl_set_id": ["4c851be4-f0d0-4b24-baf9-427ddfc6f7b0"], "pharm_class_cs": ["Benzothiazoles [CS]"], "pharm_class_epc": ["Benzothiazole [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18)", "package_ndc": "62756-538-18", "marketing_start_date": "20130618"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83)", "package_ndc": "62756-538-83", "marketing_start_date": "20130618"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86)", "package_ndc": "62756-538-86", "marketing_start_date": "20130618"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)", "package_ndc": "62756-538-88", "marketing_start_date": "20130618"}], "brand_name": "Riluzole", "product_id": "62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Benzothiazole [EPC]", "Benzothiazoles [CS]"], "product_ndc": "62756-538", "generic_name": "Riluzole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Riluzole", "active_ingredients": [{"name": "RILUZOLE", "strength": "50 mg/1"}], "application_number": "ANDA091417", "marketing_category": "ANDA", "marketing_start_date": "20130618", "listing_expiration_date": "20261231"}