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United States · US · US:0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07

EPIDUO

Orange BookUNIISPLATC D10AD

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

Identification

ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD10AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    0299590800
    1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE
  • ndc11
    0299590802
    2 g in 1 TUBE (0299-5908-02)
  • ndc11
    0299590825
    1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP
  • ndc11
    0299590845
    1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
N022320
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1L4806J2QF",
    "rxcui": "60223",
    "inchikey": "LZCDAPDGXCYOEH-UHFFFAOYSA-N",
    "display_name": "ADAPALENE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "a0610f87-3b39-458a-afa3-66be1fefd1de": {
      "match": "brand_token",
      "title": "EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]",
      "spl_version": "13",
      "published_date": "2024-10-28"
    }
  },
  "productid": "0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07",
  "productndc": "0299-5908",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022320",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1%;2.5%",
        "product_no": "001",
        "approval_date": "Dec 8, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ADAPALENE; BENZOYL PEROXIDE",
  "proprietary_name": "EPIDUO",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA022320",
  "marketing_category": "NDA",
  "nonproprietary_name": "adapalene and benzoyl peroxide",
  "start_marketing_date": "20081208",
  "active_numerator_strength": "1; 25"
}

Related drugs

Other records sharing ATC code D10AD.

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