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United States · US · US:68682-272_36b25854-8ed2-8f45-e063-6294a90a8b46

Imiquimod

Orange BookUNIISPLATC D06BB10

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

Identification

ManufacturerOceanside Pharmacueticals
CountryUS (United States)
ATC codeD06BB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6868227275
    1 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
P1QW714R7M
IMIQUIMOD
RxCUI 59943
Orange Book
N022483
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": "68682-272_36b25854-8ed2-8f45-e063-6294a90a8b46",
  "productndc": "68682-272",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "022483",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3.75%",
        "product_no": "001",
        "approval_date": "Mar 25, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.5%",
        "product_no": "002",
        "approval_date": "Jul 15, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IMIQUIMOD",
  "proprietary_name": "Imiquimod",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA022483",
  "marketing_category": "NDA",
  "nonproprietary_name": "imiquimod",
  "start_marketing_date": "20180627",
  "active_numerator_strength": "37.5"
}

Related drugs

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