🇺🇸
United States · US · US:52856-505_604ae0b3-a373-40c0-b585-419abeac74eb
EMFLAZA
Orange BookUNIISPLATC H02AB13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPTC Therapeutics, Inc.
CountryUS (United States)
ATC codeH02AB13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11528565052213 mL in 1 BOTTLE (52856-505-22)
Annotations
UNII (FDA Substance ID)
KR5YZ6AE4B
DEFLAZACORT
RxCUI 22396
Orange Book
N208685
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "KR5YZ6AE4B",
"rxcui": "22396",
"inchikey": "FBHSPRKOSMHSIF-GRMWVWQJSA-N",
"display_name": "DEFLAZACORT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"31b347d2-f156-4055-9d8f-7cf0df420296": {
"match": "brand_token",
"title": "EMFLAZA (DEFLAZACORT) TABLET EMFLAZA (DEFLAZACORT) SUSPENSION [PTC THERAPEUTICS, INC.]",
"spl_version": "21",
"published_date": "2025-12-15"
}
},
"productid": "52856-505_604ae0b3-a373-40c0-b585-419abeac74eb",
"productndc": "52856-505",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "208685",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "22.75MG/ML",
"product_no": "001",
"approval_date": "Feb 9, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEFLAZACORT",
"proprietary_name": "EMFLAZA",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208685",
"marketing_category": "NDA",
"nonproprietary_name": "deflazacort",
"start_marketing_date": "20180910",
"active_numerator_strength": "22.75"
}Related drugs
Other records sharing ATC code H02AB13.
- NOCalcortGalen Pharma GmbH
- GBCalcort 1mg tabletsShire Pharmaceuticals Ltd
- GBCalcort 30mg tabletsShire Pharmaceuticals Ltd
- GBCalcort 6mg tabletsWaymade Healthcare Plc
- GBCalcort 6mg tabletsLexon (UK) Ltd
- GBCalcort 6mg tabletsNeon Healthcare Ltd
- 🇺🇸DeflazacortUpsher-Smith Laboratories, LLC
- 🇺🇸DeflazacortSun Pharmaceutical Industries, Inc.
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