🇺🇸
United States · US · US:43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345
Synalar
Orange BookUNIISPLATC S01BA15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedimetriks Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01BA15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143538910121 TUBE in 1 CARTON (43538-910-12) / 120 g in 1 TUBE
- ndc1143538910996 TUBE in 1 CARTON (43538-910-99) / 3 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
N013960
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": {
"5af2e4c1-082b-48a0-aae7-72d4a68cbb2d": {
"match": "brand_token",
"title": "SYNALAR (FLUOCINOLONE ACETONIDE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2024-07-19"
}
},
"productid": "43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345",
"productndc": "43538-910",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "013960",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AT",
"strength": "0.025%",
"product_no": "001",
"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": "Synalar",
"active_ingred_unit": "mg/g",
"application_number": "NDA013960",
"marketing_category": "NDA",
"nonproprietary_name": "fluocinolone acetonide",
"start_marketing_date": "20120927",
"active_numerator_strength": ".25"
}Related drugs
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