Back to search
🇺🇸

United States · US · US:50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc

Fluconazole

Orange BookUNIISPLATC J02AC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5009021950
    1 BLISTER PACK in 1 CARTON (50090-2195-0) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    5009021951
    1 BLISTER PACK in 1 CARTON (50090-2195-1) / 12 TABLET in 1 BLISTER PACK
  • ndc11
    5009021952
    1 BLISTER PACK in 1 CARTON (50090-2195-2) / 2 TABLET in 1 BLISTER PACK
  • ndc11
    5009021953
    1 BLISTER PACK in 1 CARTON (50090-2195-3) / 4 TABLET in 1 BLISTER PACK

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": "50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc",
  "productndc": "50090-2195",
  "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": "150"
}

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.