Back to search
🇺🇸

United States · US · US:42291-775_4c362542-247a-50f1-e063-6394a90a5065

Riluzole

In shortageOrange BookUNIISPLATC N07XX02

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeN07XX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229177560
    60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60)

Annotations

UNII (FDA Substance ID)
7LJ087RS6F
RILUZOLE
RxCUI 35623
Orange Book
A206045
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": {
    "ccead445-970c-46a1-9532-2848cc2aa3b6": {
      "match": "brand_token",
      "title": "RILUZOLE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]",
      "spl_version": "8",
      "published_date": "2026-04-27"
    }
  },
  "productid": "42291-775_4c362542-247a-50f1-e063-6394a90a5065",
  "productndc": "42291-775",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206045",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Dec 9, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RILUZOLE",
  "shortage_reason": "Riluzole Oral Suspension",
  "shortage_status": "current",
  "proprietary_name": "Riluzole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206045",
  "marketing_category": "ANDA",
  "nonproprietary_name": "riluzole",
  "start_marketing_date": "20201007",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N07XX02.

Access this data programmatically

Query Riluzole 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.