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United States · US · US:68084-075_41c2a834-9f5a-9820-e063-6294a90ad914

Tretinoin

Orange BookUNIISPLATC D10AD51

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeD10AD51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808407521
    3 BLISTER PACK in 1 CARTON (68084-075-21) / 10 CAPSULE in 1 BLISTER PACK (68084-075-11)

Annotations

UNII (FDA Substance ID)
5688UTC01R
TRETINOIN
RxCUI 10753
Orange Book
A201687
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": "ORAL",
  "spl_meta": {
    "4b6006e3-f7a4-4823-8217-3e5b0f7e58d9": {
      "match": "brand_token",
      "title": "TRETINOIN GEL [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68084-075_41c2a834-9f5a-9820-e063-6294a90ad914",
  "productndc": "68084-075",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "201687",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRETINOIN",
  "proprietary_name": "Tretinoin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201687",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tretinoin",
  "start_marketing_date": "20130718",
  "active_numerator_strength": "10"
}

Related drugs

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