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United States · US · US:71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e

fluconazole

Orange BookUNIISPLATC J02AC01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133507690
    4 TABLET in 1 BOTTLE (71335-0769-0)
  • ndc11
    7133507691
    30 TABLET in 1 BOTTLE (71335-0769-1)
  • ndc11
    7133507692
    12 TABLET in 1 BOTTLE (71335-0769-2)
  • ndc11
    7133507693
    100 TABLET in 1 BOTTLE (71335-0769-3)
  • ndc11
    7133507694
    3 TABLET in 1 BOTTLE (71335-0769-4)
  • ndc11
    7133507695
    28 TABLET in 1 BOTTLE (71335-0769-5)
  • ndc11
    7133507696
    1 TABLET in 1 BOTTLE (71335-0769-6)
  • ndc11
    7133507697
    2 TABLET in 1 BOTTLE (71335-0769-7)
  • ndc11
    7133507698
    14 TABLET in 1 BOTTLE (71335-0769-8)
  • ndc11
    7133507699
    8 TABLET in 1 BOTTLE (71335-0769-9)

Annotations

UNII (FDA Substance ID)
8VZV102JFY
FLUCONAZOLE
RxCUI 4450
Orange Book
A208963
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": "71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e",
  "productndc": "71335-0769",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208963",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Feb 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Feb 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCONAZOLE",
  "proprietary_name": "fluconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208963",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluconazole",
  "start_marketing_date": "20170406",
  "active_numerator_strength": "200"
}

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