Back to search
🇺🇸

United States · US · US:42794-010_f1f1b263-dcab-60e7-e053-2995a90ae493

Flucytosine

Orange BookUNIISPLATC J02AX01

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

Identification

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

Packs · 1

  • ndc11
    4279401008
    30 CAPSULE in 1 BOTTLE (42794-010-08)

Annotations

UNII (FDA Substance ID)
D83282DT06
FLUCYTOSINE
RxCUI 4451
Orange Book
A201566
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": "42794-010_f1f1b263-dcab-60e7-e053-2995a90ae493",
  "productndc": "42794-010",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "201566",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCYTOSINE",
  "proprietary_name": "Flucytosine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201566",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flucytosine",
  "start_marketing_date": "20180601",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J02AX01.

Access this data programmatically

Query Flucytosine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.