Riluzole

In shortageOrange BookUNIISPLATC N07XX02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN07XX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6787728605
500 TABLET in 1 BOTTLE (67877-286-05)
ndc11
6787728610
1000 TABLET in 1 BOTTLE (67877-286-10)
ndc11
6787728614
10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK
ndc11
6787728660
60 TABLET in 1 BOTTLE (67877-286-60)
ndc11
6787728690
90 TABLET in 1 BOTTLE (67877-286-90)

Annotations

UNII (FDA Substance ID)

7LJ087RS6F

RILUZOLE

RxCUI 35623

Orange Book

A204048

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": "67877-286_ab3e90af-a9b7-4a4c-bbd9-31739b8aec19",
  "productndc": "67877-286",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204048",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2016"
      }
    ],
    "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": "ANDA204048",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Riluzole",
  "start_marketing_date": "20160331",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N07XX02.

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