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United States · US · US:40032-771_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4

Flucytosine

Orange BookUNIISPLATC J02AX01

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

Identification

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

Packs · 2

  • ndc11
    4003277101
    100 CAPSULE in 1 BOTTLE (40032-771-01)
  • ndc11
    4003277103
    30 CAPSULE in 1 BOTTLE (40032-771-03)

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": "40032-771_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4",
  "productndc": "40032-771",
  "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": "250"
}

Related drugs

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