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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

  • ndc11
    0299595002
    1 TUBE in 1 BLISTER PACK (0299-5950-02) / 3 g in 1 TUBE
  • ndc11
    0299595030
    1 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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