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United States · US · US:43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984

FINGOLIMOD

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeL04AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4354700303
    30 CAPSULE in 1 BOTTLE (43547-003-03)
  • ndc11
    4354700309
    90 CAPSULE in 1 BOTTLE (43547-003-09)

Annotations

UNII (FDA Substance ID)
3QN8BYN5QF
FINGOLIMOD
RxCUI 1012892
Orange Book
A208003
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3QN8BYN5QF",
    "rxcui": "1012892",
    "inchikey": "KKGQTZUTZRNORY-UHFFFAOYSA-N",
    "display_name": "FINGOLIMOD",
    "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": "43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984",
  "productndc": "43547-003",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINGOLIMOD",
  "proprietary_name": "FINGOLIMOD",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fingolimod",
  "start_marketing_date": "20200217",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code L04AE01.

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