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United States · US · US:0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5
TRI-LUMA
Orange BookUNIISPLATC C05AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeC05AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1102995950021 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE
- ndc1102995950301 TUBE in 1 CARTON (0299-5950-30) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
N021112
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0CD5FD6S2M",
"rxcui": "4461",
"inchikey": "FEBLZLNTKCEFIT-VSXGLTOVSA-N",
"display_name": "FLUOCINOLONE ACETONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"a35fa709-5eb5-4429-b38f-f1e0019bf0ee": {
"match": "brand_token",
"title": "TRI-LUMA (FLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOIN) CREAM [GALDERMA LABORATORIES, L.P.]",
"spl_version": "18",
"published_date": "2024-10-28"
}
},
"productid": "0299-5950_253d914c-6f0e-c833-e063-6394a90a7ca5",
"productndc": "0299-5950",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "021112",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.01%;4%;0.05%",
"product_no": "001",
"approval_date": "Jan 18, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN",
"proprietary_name": "TRI-LUMA",
"active_ingred_unit": "mg/g; mg/g; mg/g",
"application_number": "NDA021112",
"marketing_category": "NDA",
"nonproprietary_name": "fluocinolone acetonide, hydroquinone, and tretinoin",
"start_marketing_date": "20020118",
"active_numerator_strength": ".1; 40; .5"
}Related drugs
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