Fingolimod

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeL04AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6787747630
30 CAPSULE in 1 BOTTLE (67877-476-30)
ndc11
6787747632
7 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACK
ndc11
6787747633
10 BLISTER PACK in 1 CARTON (67877-476-33) / 10 CAPSULE in 1 BLISTER PACK
ndc11
6787747656
28 CAPSULE in 1 BOTTLE (67877-476-56)
ndc11
6787747658
28 BLISTER PACK in 1 CARTON (67877-476-58) / 14 CAPSULE in 1 BLISTER PACK (67877-476-14)

Annotations

UNII (FDA Substance ID)

G926EC510T

FINGOLIMOD HYDROCHLORIDE

RxCUI 1012891

Orange Book

A208004

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": "67877-476_d2f337fa-908a-4ae9-bcfd-59dcc4353705",
  "productndc": "67877-476",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208004",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 2020"
      }
    ],
    "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": "ANDA208004",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fingolimod hydrochloride",
  "start_marketing_date": "20220921",
  "active_numerator_strength": ".5"
}

Related drugs

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