riluzole

Generic: riluzole

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name riluzole
Generic Name riluzole
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

riluzole 50 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-286
Product ID 67877-286_ab3e90af-a9b7-4a4c-bbd9-31739b8aec19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204048
Listing Expiration 2026-12-31
Marketing Start 2016-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877286
Hyphenated Format 67877-286

Supplemental Identifiers

RxCUI
199206
UPC
0367877286600
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 ANDA204048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-286-05)
  • 1000 TABLET in 1 BOTTLE (67877-286-10)
  • 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (67877-286-60)
  • 90 TABLET in 1 BOTTLE (67877-286-90)
source: ndc

Packages (5)

67877-286-05 500 TABLET in 1 BOTTLE (67877-286-05) 67877-286-10 1000 TABLET in 1 BOTTLE (67877-286-10) 67877-286-14 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK 67877-286-60 60 TABLET in 1 BOTTLE (67877-286-60) 67877-286-90 90 TABLET in 1 BOTTLE (67877-286-90)

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": "ab3e90af-a9b7-4a4c-bbd9-31739b8aec19", "openfda": {"nui": ["N0000175740", "M0483511"], "upc": ["0367877286600"], "unii": ["7LJ087RS6F"], "rxcui": ["199206"], "spl_set_id": ["dd432c13-389e-46b3-8891-0cf1a58800ff"], "pharm_class_cs": ["Benzothiazoles [CS]"], "pharm_class_epc": ["Benzothiazole [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-286-05)", "package_ndc": "67877-286-05", "marketing_start_date": "20160331"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-286-10)", "package_ndc": "67877-286-10", "marketing_start_date": "20160331"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-286-14)  / 14 TABLET in 1 BLISTER PACK", "package_ndc": "67877-286-14", "marketing_start_date": "20160331"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (67877-286-60)", "package_ndc": "67877-286-60", "marketing_start_date": "20160331"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-286-90)", "package_ndc": "67877-286-90", "marketing_start_date": "20160331"}], "brand_name": "Riluzole", "product_id": "67877-286_ab3e90af-a9b7-4a4c-bbd9-31739b8aec19", "dosage_form": "TABLET", "pharm_class": ["Benzothiazole [EPC]", "Benzothiazoles [CS]"], "product_ndc": "67877-286", "generic_name": "Riluzole", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Riluzole", "active_ingredients": [{"name": "RILUZOLE", "strength": "50 mg/1"}], "application_number": "ANDA204048", "marketing_category": "ANDA", "marketing_start_date": "20160331", "listing_expiration_date": "20261231"}