Nitisinone

Orange BookUNIISPLATC A16AX04

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

Identification

ManufacturerEton Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA16AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7186312260
1 BOTTLE in 1 CARTON (71863-122-60) / 60 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

A216201

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": {
    "dc5e4875-fcd7-408c-88c9-4a715f4384b6": {
      "match": "brand_token",
      "title": "NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71863-122_42c7c79b-1aa1-12bc-e063-6394a90a5ff8",
  "productndc": "71863-122",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216201",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "May 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "May 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NITISINONE",
  "proprietary_name": "Nitisinone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216201",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitisinone",
  "start_marketing_date": "20240115",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A16AX04.

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