Back to search
🇺🇸

United States · US · US:70726-0303_4746e22f-8ca7-9149-e063-6294a90aea8d

TIGLUTIK

In shortageOrange BookUNIISPLATC N07XX02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEDW PHARMA, INC
CountryUS (United States)
ATC codeN07XX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7072603031
    2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-1) / 300 mL in 1 BOTTLE, PLASTIC (70726-0303-2)

Annotations

UNII (FDA Substance ID)
7LJ087RS6F
RILUZOLE
RxCUI 35623
Orange Book
N209080
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Riluzole Oral Suspension
Raw payload (JSON)
{
  "unii": {
    "unii": "7LJ087RS6F",
    "rxcui": "35623",
    "inchikey": "FTALBRSUTCGOEG-UHFFFAOYSA-N",
    "display_name": "RILUZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "75d68f19-4208-109e-e053-2991aa0ac857": {
      "match": "brand_token",
      "title": "TIGLUTIK (RILUZOLE) LIQUID [EDW PHARMA, INC]",
      "spl_version": "21",
      "published_date": "2026-01-06"
    }
  },
  "productid": "70726-0303_4746e22f-8ca7-9149-e063-6294a90aea8d",
  "productndc": "70726-0303",
  "dosage_form": "LIQUID",
  "orange_book": {
    "appl_no": "209080",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG/10ML",
        "product_no": "001",
        "approval_date": "Sep 5, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RILUZOLE",
  "shortage_reason": "Riluzole Oral Suspension",
  "shortage_status": "current",
  "proprietary_name": "TIGLUTIK",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA209080",
  "marketing_category": "NDA",
  "nonproprietary_name": "Riluzole",
  "start_marketing_date": "20180921",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N07XX02.

Access this data programmatically

Query TIGLUTIK and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.