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United States · US · US:0299-5935_21db90dd-c7e5-79d1-e063-6294a90ab57e

AKLIEF

Orange BookUNIISPLATC D10AD06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD10AD06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0299593502
    1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE
  • ndc11
    0299593545
    1 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
0J8RN2W0HK
TRIFAROTENE
RxCUI 2205637
Orange Book
N211527
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0J8RN2W0HK",
    "rxcui": "2205637",
    "inchikey": "MFBCDACCJCDGBA-UHFFFAOYSA-N",
    "display_name": "TRIFAROTENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "62d910db-85a6-4696-b69b-4bd2f3080cfc": {
      "match": "brand_token",
      "title": "AKLIEF (TRIFAROTENE) CREAM [GALDERMA LABORATORIES, L.P.]",
      "spl_version": "7",
      "published_date": "2024-09-18"
    }
  },
  "productid": "0299-5935_21db90dd-c7e5-79d1-e063-6294a90ab57e",
  "productndc": "0299-5935",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "211527",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005%",
        "product_no": "001",
        "approval_date": "Oct 4, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIFAROTENE",
  "proprietary_name": "AKLIEF",
  "active_ingred_unit": "ug/g",
  "application_number": "NDA211527",
  "marketing_category": "NDA",
  "nonproprietary_name": "trifarotene",
  "start_marketing_date": "20191004",
  "active_numerator_strength": "50"
}

Related drugs

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