Nitisinone

Orange BookUNIISPLATC A16AX04

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

Identification

ManufacturerAnalog Pharma

CountryUS (United States)

ATC codeA16AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7050520260
1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

K5BN214699

NITISINONE

RxCUI 61805

Orange Book

A212390

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": "70505-202_f74e0d5c-aaae-4751-a24d-4d141dfcae61",
  "productndc": "70505-202",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212390",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "May 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Apr 27, 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": "ANDA212390",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nitisinone",
  "start_marketing_date": "20220615",
  "active_numerator_strength": "2"
}

Related drugs

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