FLUCONAZOLE

Orange BookUNIISPLATC J02AC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

Manufacturerdirect rx

CountryUS (United States)

ATC codeJ02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218914301
1 TABLET in 1 DOSE PACK (72189-143-01)

Annotations

UNII (FDA Substance ID)

8VZV102JFY

FLUCONAZOLE

RxCUI 4450

Orange Book

A076658

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": "72189-143_2becff06-7cc2-1200-e063-6294a90ad1ec",
  "productndc": "72189-143",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076658",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jul 29, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "FLUCONAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076658",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLUCONAZOLE",
  "start_marketing_date": "20201112",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code J02AC01.

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