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United States · US · US:50090-6780_8c4a99cd-34c1-45e0-9936-a9f5cc04f6b7

Fluocinolone Acetonide

Orange BookUNIISPLATC S01BA15

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeS01BA15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009067800
    118.28 mL in 1 BOTTLE (50090-6780-0)

Annotations

UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A090982
AT
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": "TOPICAL",
  "spl_meta": {
    "4790bdfa-c964-4c3e-9d01-c2fb23a0172e": {
      "match": "brand_token",
      "title": "FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50090-6780_8c4a99cd-34c1-45e0-9936-a9f5cc04f6b7",
  "productndc": "50090-6780",
  "dosage_form": "OIL",
  "orange_book": {
    "appl_no": "090982",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Apr 25, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE",
  "proprietary_name": "Fluocinolone Acetonide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090982",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluocinolone Acetonide",
  "start_marketing_date": "20160718",
  "active_numerator_strength": ".11"
}

Related drugs

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