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United States · US · US:43386-770_f404c3d3-ea62-4918-aebd-58b00b661bb9

Flucytosine

Orange BookUNIISPLATC J02AX01

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ02AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4338677001
    100 CAPSULE in 1 BOTTLE (43386-770-01)

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": "43386-770_f404c3d3-ea62-4918-aebd-58b00b661bb9",
  "productndc": "43386-770",
  "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": "20170707",
  "active_numerator_strength": "500"
}

Related drugs

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