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United States · US · US:99207-276_1216e839-274f-412d-953f-ce56f0cd42a2
Zyclara
Orange BookUNIISPLATC D06BB10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD06BB10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1199207276011 BOTTLE, PUMP in 1 CARTON (99207-276-01) / 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": {
"28cd9b5b-680b-480f-b33d-9c5b52bbf03d": {
"match": "brand_token",
"title": "ZYCLARA (IMIQUIMOD) CREAM [BAUSCH HEALTH US, LLC]",
"spl_version": "23",
"published_date": "2026-02-16"
}
},
"productid": "99207-276_1216e839-274f-412d-953f-ce56f0cd42a2",
"productndc": "99207-276",
"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": "Zyclara",
"active_ingred_unit": "mg/g",
"application_number": "NDA022483",
"marketing_category": "NDA",
"nonproprietary_name": "imiquimod",
"start_marketing_date": "20120229",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code D06BB10.
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