Fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeJ02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8706320401
1 TABLET in 1 BOTTLE (87063-204-01)
ndc11
8706320407
7 TABLET in 1 BOTTLE (87063-204-07)
ndc11
8706320410
10 TABLET in 1 BOTTLE (87063-204-10)
ndc11
8706320414
14 TABLET in 1 BOTTLE (87063-204-14)
ndc11
8706320420
20 TABLET in 1 BOTTLE (87063-204-20)
ndc11
8706320430
30 TABLET in 1 BOTTLE (87063-204-30)
ndc11
8706320460
60 TABLET in 1 BOTTLE (87063-204-60)
ndc11
8706320490
90 TABLET in 1 BOTTLE (87063-204-90)

Annotations

UNII (FDA Substance ID)

8VZV102JFY

FLUCONAZOLE

RxCUI 4450

Orange Book

A077731

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": "87063-204_52428ad6-384c-5071-e063-6294a90ac345",
  "productndc": "87063-204",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077731",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Oct 7, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Oct 7, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Oct 7, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "Fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077731",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluconazole",
  "start_marketing_date": "20081007",
  "active_numerator_strength": "100"
}

Related drugs

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