🇺🇸
United States · US · US:69238-1534_64167760-d963-439f-ac85-21eefb5e8b39
Fluocinonide Cream
Orange BookUNIISPLATC C05AA11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeC05AA11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1169238153421 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE
- ndc1169238153431 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE
- ndc1169238153451 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE
- ndc1169238153461 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A210554
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2W4A77YPAN",
"rxcui": "4462",
"inchikey": "WJOHZNCJWYWUJD-IUGZLZTKSA-N",
"display_name": "FLUOCINONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"38a36184-22b4-4e97-83e1-fdd984ef6ccb": {
"match": "brand_token",
"title": "FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-05-20"
}
},
"productid": "69238-1534_64167760-d963-439f-ac85-21eefb5e8b39",
"productndc": "69238-1534",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "210554",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB1",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Aug 21, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUOCINONIDE",
"proprietary_name": "Fluocinonide Cream",
"active_ingred_unit": "mg/g",
"application_number": "ANDA210554",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluocinonide",
"start_marketing_date": "20171001",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code C05AA11.
- 🇺🇸fluocinonideNovel Laboratories, Inc.
- 🇺🇸fluocinonideE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- 🇺🇸fluocinonideBryant Ranch Prepack
- 🇺🇸FluocinonideSun Pharmaceutical Industries, Inc.
- 🇺🇸FluocinonideCosette Pharmaceuticals, Inc.
- 🇺🇸FluocinonideNuCare Pharmaceuticals,Inc.
- 🇺🇸FluocinonideBryant Ranch Prepack
- 🇺🇸FluocinonideGlenmark Pharmaceuticals Inc., USA
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