DERMOTIC

Orange BookUNIISPLATC S01BA15

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

Identification

ManufacturerRoyal Pharmaceuticals

CountryUS (United States)

ATC codeS01BA15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6879110320
1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

0CD5FD6S2M

FLUOCINOLONE ACETONIDE

RxCUI 4461

Orange Book

N019452

ATATAT

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0CD5FD6S2M",
    "rxcui": "4461",
    "inchikey": "FEBLZLNTKCEFIT-VSXGLTOVSA-N",
    "display_name": "FLUOCINOLONE ACETONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "AURICULAR (OTIC)",
  "spl_meta": {
    "eb00f222-8105-4e05-90e8-bbd129784364": {
      "match": "brand_token",
      "title": "DERMOTIC (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]",
      "spl_version": "14",
      "published_date": "2025-05-12"
    }
  },
  "productid": "68791-103_195c48d9-bb7a-4c89-b6b8-35fff5aefff8",
  "productndc": "68791-103",
  "dosage_form": "OIL",
  "orange_book": {
    "appl_no": "019452",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Feb 3, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "002",
        "approval_date": "Nov 9, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "003",
        "approval_date": "Nov 9, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE",
  "proprietary_name": "DERMOTIC",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019452",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluocinolone acetonide",
  "start_marketing_date": "20051109",
  "active_numerator_strength": ".11"
}

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