tiglutik

Generic: riluzole

Labeler: edw pharma, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiglutik
Generic Name riluzole
Labeler edw pharma, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

riluzole 50 mg/10mL

Manufacturer
EDW PHARMA, INC

Identifiers & Regulatory

Product NDC 70726-0303
Product ID 70726-0303_4746e22f-8ca7-9149-e063-6294a90aea8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209080
Listing Expiration 2027-12-31
Marketing Start 2018-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707260303
Hyphenated Format 70726-0303

Supplemental Identifiers

RxCUI
2058147 2059266
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 tiglutik (source: ndc)
Generic Name riluzole (source: ndc)
Application Number NDA209080 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2)
source: ndc

Packages (1)

70726-0303-1 2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2)

Ingredients (1)

riluzole (50 mg/10mL)

Linked Drug Pages (1)

TIGLUTIK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4746e22f-8ca7-9149-e063-6294a90aea8d", "openfda": {"nui": ["N0000175740", "M0483511"], "unii": ["7LJ087RS6F"], "rxcui": ["2058147", "2059266"], "spl_set_id": ["75d68f19-4208-109e-e053-2991aa0ac857"], "pharm_class_cs": ["Benzothiazoles [CS]"], "pharm_class_epc": ["Benzothiazole [EPC]"], "manufacturer_name": ["EDW PHARMA, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1)  / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2)", "package_ndc": "70726-0303-1", "marketing_start_date": "20180921"}], "brand_name": "TIGLUTIK", "product_id": "70726-0303_4746e22f-8ca7-9149-e063-6294a90aea8d", "dosage_form": "LIQUID", "pharm_class": ["Benzothiazole [EPC]", "Benzothiazoles [CS]"], "product_ndc": "70726-0303", "generic_name": "Riluzole", "labeler_name": "EDW PHARMA, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIGLUTIK", "active_ingredients": [{"name": "RILUZOLE", "strength": "50 mg/10mL"}], "application_number": "NDA209080", "marketing_category": "NDA", "marketing_start_date": "20180921", "listing_expiration_date": "20271231"}