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United States · US · US:51672-4174_48e9d045-e9a2-8452-e063-6294a90af1e9

Imiquimod

Orange BookUNIISPLATC D06BB10

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD06BB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167241746
    28 PACKET in 1 CARTON (51672-4174-6) / .25 g in 1 PACKET (51672-4174-8)
  • ndc11
    5167241749
    1 BOTTLE, PUMP in 1 CARTON (51672-4174-9) / 7.5 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
P1QW714R7M
IMIQUIMOD
RxCUI 59943
Orange Book
A205971
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": "51672-4174_48e9d045-e9a2-8452-e063-6294a90af1e9",
  "productndc": "51672-4174",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "205971",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75%",
        "product_no": "001",
        "approval_date": "Jan 26, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IMIQUIMOD",
  "proprietary_name": "Imiquimod",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA205971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Imiquimod",
  "start_marketing_date": "20210126",
  "active_numerator_strength": "37.5"
}

Related drugs

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