Tretinoin

Orange BookUNIISPLATC D10AD51

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOceanside Pharmaceuticals

CountryUS (United States)

ATC codeD10AD51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6868251595
1 BOTTLE, PUMP in 1 CARTON (68682-515-95) / 50 g in 1 BOTTLE, PUMP

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": {
    "4b6006e3-f7a4-4823-8217-3e5b0f7e58d9": {
      "match": "brand_token",
      "title": "TRETINOIN GEL [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "68682-515_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a",
  "productndc": "68682-515",
  "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": "Tretinoin",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020475",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tretinoin",
  "start_marketing_date": "20231201",
  "active_numerator_strength": ".8"
}

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