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United States · US · US:42385-984_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889

Flucytosine

Orange BookUNIISPLATC J02AX01

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

Identification

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

Packs · 2

  • ndc11
    4238598401
    100 CAPSULE in 1 BOTTLE (42385-984-01)
  • ndc11
    4238598427
    10 BLISTER PACK in 1 CARTON (42385-984-27) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
D83282DT06
FLUCYTOSINE
RxCUI 4451
Orange Book
A218005
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": "42385-984_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889",
  "productndc": "42385-984",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218005",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCYTOSINE",
  "proprietary_name": "Flucytosine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218005",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flucytosine",
  "start_marketing_date": "20250724",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J02AX01.

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