emflaza

Generic: deflazacort

Labeler: ptc therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name emflaza
Generic Name deflazacort
Labeler ptc therapeutics, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

deflazacort 22.75 mg/mL

Manufacturer
PTC Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 52856-505
Product ID 52856-505_604ae0b3-a373-40c0-b585-419abeac74eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208685
Listing Expiration 2026-12-31
Marketing Start 2018-09-10

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52856505
Hyphenated Format 52856-505

Supplemental Identifiers

RxCUI
153098 153880 1870950 1870952 1870954 1870956 1870958 1870960 1870964 1870968
UNII
KR5YZ6AE4B
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name emflaza (source: ndc)
Generic Name deflazacort (source: ndc)
Application Number NDA208685 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 22.75 mg/mL
source: ndc
Packaging
  • 13 mL in 1 BOTTLE (52856-505-22)
source: ndc

Packages (1)

52856-505-22 13 mL in 1 BOTTLE (52856-505-22)

Ingredients (1)

deflazacort (22.75 mg/mL)

Linked Drug Pages (1)

EMFLAZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "604ae0b3-a373-40c0-b585-419abeac74eb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["KR5YZ6AE4B"], "rxcui": ["153098", "153880", "1870950", "1870952", "1870954", "1870956", "1870958", "1870960", "1870964", "1870968"], "spl_set_id": ["31b347d2-f156-4055-9d8f-7cf0df420296"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PTC Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "13 mL in 1 BOTTLE (52856-505-22)", "package_ndc": "52856-505-22", "marketing_start_date": "20190830"}], "brand_name": "EMFLAZA", "product_id": "52856-505_604ae0b3-a373-40c0-b585-419abeac74eb", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "52856-505", "generic_name": "deflazacort", "labeler_name": "PTC Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EMFLAZA", "active_ingredients": [{"name": "DEFLAZACORT", "strength": "22.75 mg/mL"}], "application_number": "NDA208685", "marketing_category": "NDA", "marketing_start_date": "20180910", "listing_expiration_date": "20261231"}