FINGOLIMOD

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerQuallent Pharmaceuticals Health LLC

CountryUS (United States)

ATC codeL04AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8200914330
30 CAPSULE in 1 BOTTLE (82009-143-30)

Annotations

UNII (FDA Substance ID)

G926EC510T

FINGOLIMOD HYDROCHLORIDE

RxCUI 1012891

Orange Book

A207979

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "G926EC510T",
    "rxcui": "1012891",
    "inchikey": "SWZTYAVBMYWFGS-UHFFFAOYSA-N",
    "display_name": "FINGOLIMOD HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e1960f9b-f739-452c-b167-245551bf3690": {
      "match": "brand_token",
      "title": "FINGOLIMOD CAPSULE [CIVICASCRIPT LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "82009-143_c10504a7-d1e3-b3d2-2b35-43f1e602d8c9",
  "productndc": "82009-143",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207979",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 4, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINGOLIMOD HYDROCHLORIDE",
  "proprietary_name": "FINGOLIMOD",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207979",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FINGOLIMOD",
  "start_marketing_date": "20240328",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code L04AE01.

Access this data programmatically

Query FINGOLIMOD 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.

Get a free API key Read the API docs