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United States · US · US:45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600
Imiquimod
Orange BookUNIISPLATC D06BB10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD06BB10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11458023685312 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET
- ndc11458023686224 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKET
Annotations
UNII (FDA Substance ID)
P1QW714R7M
IMIQUIMOD
RxCUI 59943
Orange Book
A078837
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": "45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600",
"productndc": "45802-368",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "078837",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Sep 7, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IMIQUIMOD",
"proprietary_name": "Imiquimod",
"active_ingred_unit": "mg/.25g",
"application_number": "ANDA078837",
"marketing_category": "ANDA",
"nonproprietary_name": "Imiquimod",
"start_marketing_date": "20101109",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code D06BB10.
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