ELIMITE

Orange BookUNIISPLATC P03AC04

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeP03AC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965183460
1 TUBE in 1 CARTON (59651-834-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

509F88P9SZ

PERMETHRIN

RxCUI 33199

Orange Book

N019855

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "509F88P9SZ",
    "rxcui": "33199",
    "inchikey": null,
    "display_name": "PERMETHRIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "443c0446-ccba-4f52-83ed-4c3163f35807": {
      "match": "brand_token",
      "title": "ELIMITE (PERMETHRIN) CREAM [AUROBINDO PHARMA LIMITED]",
      "spl_version": "1",
      "published_date": "2024-01-25"
    }
  },
  "productid": "59651-834_443c0446-ccba-4f52-83ed-4c3163f35807",
  "productndc": "59651-834",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "019855",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Aug 25, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PERMETHRIN",
  "proprietary_name": "ELIMITE",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA019855",
  "marketing_category": "NDA",
  "nonproprietary_name": "permethrin",
  "start_marketing_date": "20240122",
  "active_numerator_strength": "50"
}

Related drugs

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