Orfadin

Orange BookUNIISPLATC A16AX04

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

Identification

ManufacturerSWEDISH ORPHAN BIOVITRUM AB (PUBL)

CountryUS (United States)

ATC codeA16AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6665811060
1 BOTTLE, PLASTIC in 1 CARTON (66658-110-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

N021232

ABABABAB

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": {
    "00307f42-748d-4227-8c6f-ed5f0a89ae0a": {
      "match": "brand_token",
      "title": "ORFADIN (NITISINONE) SUSPENSION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]",
      "spl_version": "12",
      "published_date": "2025-12-22"
    }
  },
  "productid": "66658-110_f9c6cef5-fb71-4cb0-9793-5c23ac04572e",
  "productndc": "66658-110",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021232",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 18, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jan 18, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Jun 13, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITISINONE",
  "proprietary_name": "Orfadin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021232",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nitisinone",
  "start_marketing_date": "20160701",
  "active_numerator_strength": "10"
}

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