fluocinolone acetonide

Orange BookUNIISPLATC S01BA15

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeS01BA15

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6255928915
1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBE
ndc11
6255928960
1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

0CD5FD6S2M

FLUOCINOLONE ACETONIDE

RxCUI 4461

Orange Book

N012787

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": "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": "62559-289_9a3159b1-5a5c-4784-8f61-a132de5c4608",
  "productndc": "62559-289",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "012787",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.025%",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.025%",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE",
  "proprietary_name": "fluocinolone acetonide",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA012787",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "fluocinolone acetonide",
  "start_marketing_date": "20240508",
  "active_numerator_strength": ".25"
}

Related drugs

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