FINGOLIMOD HYDROCHLORIDE

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeL04AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672934210
30 CAPSULE in 1 BOTTLE (16729-342-10)

Annotations

UNII (FDA Substance ID)

G926EC510T

FINGOLIMOD HYDROCHLORIDE

RxCUI 1012891

Orange Book

A207991

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": "16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd",
  "productndc": "16729-342",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207991",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 28, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FINGOLIMOD HYDROCHLORIDE",
  "proprietary_name": "FINGOLIMOD HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207991",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FINGOLIMOD HYDROCHLORIDE",
  "start_marketing_date": "20221018",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code L04AE01.

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