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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
- ndc1143538940601 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE
- ndc1143538940994 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
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