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United States · US · US:50268-332_47e543f6-6e53-a812-e063-6294a90accbe

Flucytosine

Orange BookUNIISPLATC J02AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAvPAK
CountryUS (United States)
ATC codeJ02AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5026833212
    20 BLISTER PACK in 1 BOX (50268-332-12) / 1 CAPSULE in 1 BLISTER PACK (50268-332-11)

Annotations

UNII (FDA Substance ID)
D83282DT06
FLUCYTOSINE
RxCUI 4451
Orange Book
A204652
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "D83282DT06",
    "rxcui": "4451",
    "inchikey": "XRECTZIEBJDKEO-UHFFFAOYSA-N",
    "display_name": "FLUCYTOSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bfc817db-ab65-5cd7-e053-2995a90a8ee8": {
      "match": "brand_token",
      "title": "FLUCYTOSINE CAPSULE [AVPAK]",
      "spl_version": "4",
      "published_date": "2026-01-14"
    }
  },
  "productid": "50268-332_47e543f6-6e53-a812-e063-6294a90accbe",
  "productndc": "50268-332",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204652",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 7, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCYTOSINE",
  "proprietary_name": "Flucytosine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204652",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flucytosine",
  "start_marketing_date": "20210412",
  "active_numerator_strength": "500"
}

Related drugs

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