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United States · US · US:0187-5144_5eacf7df-7bdd-4401-ae28-2319c8757b4a

Retin-A MICRO

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 · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
N020475
ABAB
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": "0187-5144_5eacf7df-7bdd-4401-ae28-2319c8757b4a",
  "productndc": "0187-5144",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "020475",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Feb 7, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.04%",
        "product_no": "002",
        "approval_date": "May 10, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.08%",
        "product_no": "003",
        "approval_date": "Jan 28, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.06%",
        "product_no": "004",
        "approval_date": "Oct 23, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRETINOIN",
  "proprietary_name": "Retin-A MICRO",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020475",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tretinoin",
  "start_marketing_date": "20020510",
  "active_numerator_strength": ".4"
}

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