Fingolimod

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerDr. Reddy's Laboratories Inc

CountryUS (United States)

ATC codeL04AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4359828530
30 CAPSULE in 1 BOTTLE (43598-285-30)
ndc11
4359828531
3 BLISTER PACK in 1 CARTON (43598-285-31) / 10 CAPSULE in 1 BLISTER PACK (43598-285-79)
ndc11
4359828570
1 BLISTER PACK in 1 CARTON (43598-285-70) / 7 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

G926EC510T

FINGOLIMOD HYDROCHLORIDE

RxCUI 1012891

Orange Book

A208000

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": "43598-285_1d9a673c-7eb0-b5c3-eb90-9abce3ef9141",
  "productndc": "43598-285",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208000",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 5, 2021"
      }
    ],
    "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": "ANDA208000",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fingolimod",
  "start_marketing_date": "20221011",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code L04AE01.

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