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 · 9

ndc11
8706320600
100 TABLET in 1 BOTTLE (87063-206-00)
ndc11
8706320601
1 TABLET in 1 BOTTLE (87063-206-01)
ndc11
8706320607
7 TABLET in 1 BOTTLE (87063-206-07)
ndc11
8706320610
10 TABLET in 1 BOTTLE (87063-206-10)
ndc11
8706320614
14 TABLET in 1 BOTTLE (87063-206-14)
ndc11
8706320620
20 TABLET in 1 BOTTLE (87063-206-20)
ndc11
8706320630
30 TABLET in 1 BOTTLE (87063-206-30)
ndc11
8706320660
60 TABLET in 1 BOTTLE (87063-206-60)
ndc11
8706320690
90 TABLET in 1 BOTTLE (87063-206-90)

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": "87063-206_52428ad6-384c-5071-e063-6294a90ac345",
  "productndc": "87063-206",
  "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": "200"
}

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.

Get a free API key Read the API docs