Fingolimod

Orange BookUNIISPLATC L04AE01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL04AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6838291201
100 CAPSULE in 1 BOTTLE (68382-912-01)
ndc11
6838291206
30 CAPSULE in 1 BOTTLE (68382-912-06)
ndc11
6838291216
90 CAPSULE in 1 BOTTLE (68382-912-16)
ndc11
6838291269
1 BLISTER PACK in 1 CARTON (68382-912-69) / 7 CAPSULE in 1 BLISTER PACK
ndc11
6838291270
4 BLISTER PACK in 1 CARTON (68382-912-70) / 7 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

G926EC510T

FINGOLIMOD HYDROCHLORIDE

RxCUI 1012891

Orange Book

A207994

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": "68382-912_37d21196-e2e4-45ce-a16c-f8e8693c94de",
  "productndc": "68382-912",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207994",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 14, 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": "ANDA207994",
  "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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