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United States · US · US:0187-5172_18a7b6d8-e3c4-676f-e063-6294a90a0498

Retin-A

Orange BookUNIISPLATC D10AD51

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD10AD51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0187517215
    1 TUBE in 1 CARTON (0187-5172-15) / 15 g in 1 TUBE
  • ndc11
    0187517245
    1 TUBE in 1 CARTON (0187-5172-45) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
N017955
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5688UTC01R",
    "rxcui": "10753",
    "inchikey": "SHGAZHPCJJPHSC-YCNIQYBTSA-N",
    "display_name": "TRETINOIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "08ab7e0c-1437-455f-815c-98904d96a289": {
      "match": "brand_token",
      "title": "RETIN-A MICRO (TRETINOIN) GEL [BAUSCH HEALTH US LLC]",
      "spl_version": "23",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0187-5172_18a7b6d8-e3c4-676f-e063-6294a90a0498",
  "productndc": "0187-5172",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "017955",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRETINOIN",
  "proprietary_name": "Retin-A",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA017955",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tretinoin",
  "start_marketing_date": "19790730",
  "active_numerator_strength": ".1"
}

Related drugs

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