Nitisinone

Orange BookUNIISPLATC A16AX04

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeA16AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0254302002
1 BOTTLE in 1 CARTON (0254-3020-02) / 60 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

A211041

ABABAB

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": {
    "dc5e4875-fcd7-408c-88c9-4a715f4384b6": {
      "match": "brand_token",
      "title": "NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0254-3020_8d22274c-76b2-4da0-85e0-c0fc61c7db0e",
  "productndc": "0254-3020",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211041",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITISINONE",
  "proprietary_name": "Nitisinone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211041",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitisinone",
  "start_marketing_date": "20191004",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A16AX04.

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