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United States · US · US:68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc

Imiquimod

Orange BookUNIISPLATC D06BB10

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD06BB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846253670
    24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01)

Annotations

UNII (FDA Substance ID)
P1QW714R7M
IMIQUIMOD
RxCUI 59943
Orange Book
A201994
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P1QW714R7M",
    "rxcui": "59943",
    "inchikey": "DOUYETYNHWVLEO-UHFFFAOYSA-N",
    "display_name": "IMIQUIMOD",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "51913a5a-1cab-4b9e-b2c2-e0174062df73": {
      "match": "brand_token",
      "title": "IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "8",
      "published_date": "2026-01-26"
    }
  },
  "productid": "68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc",
  "productndc": "68462-536",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "201994",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Mar 6, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IMIQUIMOD",
  "proprietary_name": "Imiquimod",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA201994",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Imiquimod",
  "start_marketing_date": "20120306",
  "active_numerator_strength": "50"
}

Related drugs

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