NDC 42998-505

EMFLAZA

Deflazacort

EMFLAZA is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Marathon Pharmaceuticals, Llc. The primary component is Deflazacort.

• Product ID: 42998-505_4e001bac-ce04-4262-96f4-8b23161f9e55
• NDC: 42998-505
• Product Type: Human Prescription Drug
• Proprietary Name: EMFLAZA
• Generic Name: Deflazacort
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-09
• Marketing End Date: 2020-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA208685
• Labeler Name: Marathon Pharmaceuticals, LLC
• Substance Name: DEFLAZACORT
• Active Ingredient Strength: 23 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 42998-505-21

13 mL in 1 BOTTLE (42998-505-21)

• Marketing Start Date: 2017-02-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42998-505-21 [42998050521]

EMFLAZA SUSPENSION

• Marketing Category: NDA
• Application Number: NDA208685
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-09
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
DEFLAZACORT	22.75 mg/mL

OpenFDA Data

• SPL SET ID: c1d8a24e-96d4-4e3a-8f7e-b9c2dc060b1f
• Manufacturer:
  • Marathon Pharmaceuticals, LLC
• 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