Fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7120565003
3 TABLET in 1 BOTTLE (71205-650-03)
ndc11
7120565010
10 TABLET in 1 BOTTLE (71205-650-10)
ndc11
7120565020
20 TABLET in 1 BOTTLE (71205-650-20)
ndc11
7120565030
30 TABLET in 1 BOTTLE (71205-650-30)
ndc11
7120565060
60 TABLET in 1 BOTTLE (71205-650-60)
ndc11
7120565090
90 TABLET in 1 BOTTLE (71205-650-90)

Annotations

UNII (FDA Substance ID)

8VZV102JFY

FLUCONAZOLE

RxCUI 4450

Orange Book

A078423

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": "71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086",
  "productndc": "71205-650",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078423",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 7, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Mar 7, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Mar 7, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 7, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "Fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078423",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluconazole",
  "start_marketing_date": "20210422",
  "active_numerator_strength": "100"
}

Related drugs

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