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United States · US · US:71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581

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 · 2

  • ndc11
    7120579601
    1 BLISTER PACK in 1 BAG (71205-796-01) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    7120579602
    2 BLISTER PACK in 1 BAG (71205-796-02) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A077253
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": "71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581",
  "productndc": "71205-796",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 25, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 25, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jan 25, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jan 25, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "Fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluconazole",
  "start_marketing_date": "20201120",
  "active_numerator_strength": "150"
}

Related drugs

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