HARLIKU

Orange BookUNIISPLATC A16AX04

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

Identification

ManufacturerCycle Pharmaceuticals Ltd.

CountryUS (United States)

ATC codeA16AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070911260
1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

N209449

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "K5BN214699",
    "rxcui": "61805",
    "inchikey": "OUBCNLGXQFSTLU-UHFFFAOYSA-N",
    "display_name": "NITISINONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7cf67e24-d46b-4376-bbd0-0b973c406d0d": {
      "match": "brand_token",
      "title": "HARLIKU (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.]",
      "spl_version": "1",
      "published_date": "2025-07-22"
    }
  },
  "productid": "70709-112_2d883e57-720f-494e-be8f-db592ba0aa32",
  "productndc": "70709-112",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209449",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jul 26, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jul 26, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 26, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Jun 10, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITISINONE",
  "proprietary_name": "HARLIKU",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209449",
  "marketing_category": "NDA",
  "nonproprietary_name": "nitisinone",
  "start_marketing_date": "20250721",
  "active_numerator_strength": "2"
}

Related drugs

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