Back to search
🇺🇸

United States · US · US:71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680

fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120508101
    1 TABLET in 1 BLISTER PACK (71205-081-01)
  • ndc11
    7120508102
    2 TABLET in 1 BLISTER PACK (71205-081-02)
  • ndc11
    7120508104
    4 TABLET in 1 BLISTER PACK (71205-081-04)

Annotations

UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A208963
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8VZV102JFY",
    "rxcui": "4450",
    "inchikey": "RFHAOTPXVQNOHP-UHFFFAOYSA-N",
    "display_name": "FLUCONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2099c3a0-1911-4d4a-878a-36cf054bdd0b": {
      "match": "brand_token",
      "title": "FLUCONAZOLE TABLET [ASCLEMED USA INC.]",
      "spl_version": "2",
      "published_date": "2026-05-21"
    }
  },
  "productid": "71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680",
  "productndc": "71205-081",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208963",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Feb 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208963",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluconazole",
  "start_marketing_date": "20170406",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code J02AC01.

Access this data programmatically

Query fluconazole 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.