Fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeJ02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8576615601
1 TABLET in 1 BOTTLE (85766-156-01)
ndc11
8576615607
7 TABLET in 1 BOTTLE (85766-156-07)
ndc11
8576615610
10 TABLET in 1 BOTTLE (85766-156-10)
ndc11
8576615614
14 TABLET in 1 BOTTLE (85766-156-14)
ndc11
8576615620
20 TABLET in 1 BOTTLE (85766-156-20)
ndc11
8576615630
30 TABLET in 1 BOTTLE (85766-156-30)
ndc11
8576615660
60 TABLET in 1 BOTTLE (85766-156-60)
ndc11
8576615690
90 TABLET in 1 BOTTLE (85766-156-90)

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": "85766-156_4a5ea753-6b40-6c06-e063-6294a90ae2b5",
  "productndc": "85766-156",
  "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": "50"
}

Related drugs

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