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United States · US · US:43538-940_b176bc29-53fc-48a1-bf09-ba250f1d13d7

Neo-Synalar

Orange BookUNIISPLATC C05AA

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

Identification

ManufacturerEurofarma, Inc.
CountryUS (United States)
ATC codeC05AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4353894060
    1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE
  • ndc11
    4353894099
    4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
A060700
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": {
    "1141956e-8a4c-4f80-95d1-f15bdb57fdf6": {
      "match": "brand_token",
      "title": "NEO-SYNALAR (NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE) CREAM [EUROFARMA, INC.]",
      "spl_version": "5",
      "published_date": "2026-03-20"
    }
  },
  "productid": "43538-940_b176bc29-53fc-48a1-bf09-ba250f1d13d7",
  "productndc": "43538-940",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "060700",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.025%;EQ 3.5MG BASE/GM",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE",
  "proprietary_name": "Neo-Synalar",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA060700",
  "marketing_category": "ANDA",
  "nonproprietary_name": "neomycin sulfate and fluocinolone acetonide",
  "start_marketing_date": "19630611",
  "active_numerator_strength": ".25; 3.5"
}

Related drugs

Other records sharing ATC code C05AA.

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