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United States · US · US:0713-0804_0b4b0b29-a411-44a4-e063-6294a90ab3ba
TAZAROTENE
Orange BookUNIISPLATC D05AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD05AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107130804311 TUBE in 1 CARTON (0713-0804-31) / 30 g in 1 TUBE
- ndc1107130804991 TUBE in 1 CARTON (0713-0804-99) / 100 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
81BDR9Y8PS
TAZAROTENE
RxCUI 83947
Orange Book
A214136
AB
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": "0713-0804_0b4b0b29-a411-44a4-e063-6294a90ab3ba",
"productndc": "0713-0804",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "214136",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Sep 13, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAZAROTENE",
"proprietary_name": "TAZAROTENE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA214136",
"marketing_category": "ANDA",
"nonproprietary_name": "tazarotene",
"start_marketing_date": "20220914",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code D05AX05.
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