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United States · US · US:85766-102_5031f501-a03c-c192-e063-6294a90ae96c

Fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    8576610200
    10 DOSE PACK in 1 CARTON (85766-102-00) / 10 TABLET in 1 DOSE PACK
  • ndc11
    8576610201
    100 TABLET in 1 BOTTLE (85766-102-01)
  • ndc11
    8576610205
    500 TABLET in 1 BOTTLE (85766-102-05)
  • ndc11
    8576610210
    10 TABLET in 1 BOTTLE (85766-102-10)
  • ndc11
    8576610212
    12 TABLET in 1 BOTTLE (85766-102-12)
  • ndc11
    8576610220
    20 TABLET in 1 BOTTLE (85766-102-20)
  • ndc11
    8576610230
    30 TABLET in 1 BOTTLE (85766-102-30)
  • ndc11
    8576610260
    60 TABLET in 1 BOTTLE (85766-102-60)
  • ndc11
    8576610290
    90 TABLET in 1 BOTTLE (85766-102-90)

Annotations

UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A076658
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": "85766-102_5031f501-a03c-c192-e063-6294a90ae96c",
  "productndc": "85766-102",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076658",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jul 29, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "Fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076658",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluconazole",
  "start_marketing_date": "20140620",
  "active_numerator_strength": "100"
}

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