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United States · US · US:16110-916_ee97b76e-eb11-4165-ae85-1277eba9ff35
TAZORAC
Orange BookUNIISPLATC D05AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmirall, LLC
CountryUS (United States)
ATC codeD05AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116110916301 TUBE in 1 CARTON (16110-916-30) / 30 g in 1 TUBE
- ndc1116110916601 TUBE in 1 CARTON (16110-916-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
N021184
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "81BDR9Y8PS",
"rxcui": "83947",
"inchikey": "OGQICQVSFDPSEI-UHFFFAOYSA-N",
"display_name": "TAZAROTENE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "CUTANEOUS",
"spl_meta": {
"4e4e4b81-420e-4492-8a74-80b692a80057": {
"match": "brand_token",
"title": "TAZORAC (TAZAROTENE) GEL [ALMIRALL, LLC]",
"spl_version": "4",
"published_date": "2025-11-18"
}
},
"productid": "16110-916_ee97b76e-eb11-4165-ae85-1277eba9ff35",
"productndc": "16110-916",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "021184",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Sep 29, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.1%",
"product_no": "002",
"approval_date": "Sep 29, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.1%",
"product_no": "003",
"approval_date": "Sep 30, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAZAROTENE",
"proprietary_name": "TAZORAC",
"active_ingred_unit": "mg/g",
"application_number": "NDA021184",
"marketing_category": "NDA",
"nonproprietary_name": "tazarotene",
"start_marketing_date": "20200203",
"active_numerator_strength": ".1"
}Related drugs
Other records sharing ATC code D05AX05.
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