NDC 52856-503

EMFLAZA

Deflazacort

EMFLAZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ptc Therapeutics, Inc.. The primary component is Deflazacort.

• Product ID: 52856-503_093eae66-8239-47c7-8cc7-9b4be164fb70
• NDC: 52856-503
• Product Type: Human Prescription Drug
• Proprietary Name: EMFLAZA
• Generic Name: Deflazacort
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA208684
• Labeler Name: PTC Therapeutics, Inc.
• Substance Name: DEFLAZACORT
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 52856-503-03

30 TABLET in 1 BOTTLE (52856-503-03)

• Marketing Start Date: 2018-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52856-503-03 [52856050303]

EMFLAZA TABLET

• Marketing Category: NDA
• Application Number: NDA208684
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-09-10

Drug Details

Active Ingredients

Ingredient	Strength
DEFLAZACORT	30 mg/1

OpenFDA Data

• SPL SET ID: 31b347d2-f156-4055-9d8f-7cf0df420296
• Manufacturer:
  • PTC Therapeutics, Inc.
• UNII:
  • KR5YZ6AE4B
• RxNorm Concept Unique ID - RxCUI:
  • 1870964
  • 1870960
  • 153880
  • 1870968
  • 1870958
  • 1870956
  • 1870954
  • 1870952
  • 153098
  • 1870950

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "EMFLAZA" or generic name "Deflazacort"

NDC	Brand Name	Generic Name
42998-501	EMFLAZA	deflazacort
42998-502	EMFLAZA	deflazacort
42998-503	EMFLAZA	deflazacort
42998-504	EMFLAZA	deflazacort
42998-505	EMFLAZA	deflazacort
52856-501	EMFLAZA	deflazacort
52856-502	EMFLAZA	deflazacort
52856-503	EMFLAZA	deflazacort
52856-504	EMFLAZA	deflazacort
52856-505	EMFLAZA	deflazacort