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
6665820490
1 BOTTLE, GLASS in 1 CARTON (66658-204-90) / 90 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

N206356

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": "66658-204_463bdca4-b840-6f9f-e063-6294a90ab3b5",
  "productndc": "66658-204",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "206356",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/ML",
        "product_no": "001",
        "approval_date": "Apr 22, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITISINONE",
  "proprietary_name": "ORFADIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA206356",
  "marketing_category": "NDA",
  "nonproprietary_name": "nitisinone",
  "start_marketing_date": "20160601",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code A16AX04.

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