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United States · US · US:71335-2879_0cd1128a-9159-4955-849b-054c9444ad0a

FLUOCINOLONE ACETONIDE

Orange BookUNIISPLATC S01BA15

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeS01BA15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133528791
    1 BOTTLE in 1 CARTON (71335-2879-1) / 20 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A212762
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": "AURICULAR (OTIC)",
  "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": "71335-2879_0cd1128a-9159-4955-849b-054c9444ad0a",
  "productndc": "71335-2879",
  "dosage_form": "OIL",
  "orange_book": {
    "appl_no": "212762",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Apr 2, 2021"
      }
    ],
    "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": "ANDA212762",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluocinolone acetonide",
  "start_marketing_date": "20210402",
  "active_numerator_strength": ".11"
}

Related drugs

Other records sharing ATC code S01BA15.

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