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United States · US · US:45802-436_710d0db0-54af-49fd-b2ed-77582a4b3238
TAZAROTENE
Orange BookUNIISPLATC D05AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD05AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1145802436011 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE
- ndc1145802436941 TUBE in 1 CARTON (45802-436-94) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
A213079
ABAB
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": "TOPICAL",
"spl_meta": {
"478ff059-9d7b-438e-a64e-c853dfac2872": {
"match": "brand_token",
"title": "TAZAROTENE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "6",
"published_date": "2025-12-22"
}
},
"productid": "45802-436_710d0db0-54af-49fd-b2ed-77582a4b3238",
"productndc": "45802-436",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "213079",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Apr 25, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "002",
"approval_date": "Apr 25, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAZAROTENE",
"proprietary_name": "TAZAROTENE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA213079",
"marketing_category": "ANDA",
"nonproprietary_name": "tazarotene",
"start_marketing_date": "20230605",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code D05AX05.
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