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United States · US · US:51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5

Econazole Nitrate

Orange BookUNIISPLATC D01AC03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD01AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5167213031
    1 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE
  • ndc11
    5167213032
    1 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE
  • ndc11
    5167213038
    1 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
H438WYN10E
ECONAZOLE NITRATE
RxCUI 142434
Orange Book
A076005
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H438WYN10E",
    "rxcui": "142434",
    "inchikey": "DDXORDQKGIZAME-UHFFFAOYSA-N",
    "display_name": "ECONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "74e5bbc9-eaea-405e-b64b-b3527c5ea084": {
      "match": "brand_token",
      "title": "ECONAZOLE NITRATE CREAM [AUROBINDO PHARMA LIMITED]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5",
  "productndc": "51672-1303",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "076005",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Nov 26, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ECONAZOLE NITRATE",
  "proprietary_name": "Econazole Nitrate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA076005",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Econazole Nitrate",
  "start_marketing_date": "20021126",
  "active_numerator_strength": "10"
}

Related drugs

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