NDC 58463-016

Decadron

Dexamethasone

Decadron is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pragma Pharmaceuticals, Llc. The primary component is Dexamethasone.

• Product ID: 58463-016_2f2e5809-635f-4b7f-81d3-71493f46895a
• NDC: 58463-016
• Product Type: Human Prescription Drug
• Proprietary Name: Decadron
• Generic Name: Dexamethasone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-02-28
• Marketing End Date: 2022-03-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088481
• Labeler Name: Pragma Pharmaceuticals, LLC
• Substance Name: DEXAMETHASONE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 58463-016-01

100 TABLET in 1 BOTTLE (58463-016-01)

• Marketing Start Date: 2018-02-28
• Marketing End Date: 2022-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58463-016-01 [58463001601]

Decadron TABLET

• Marketing Category: ANDA
• Application Number: ANDA088481
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-28

Drug Details

Active Ingredients

Ingredient	Strength
DEXAMETHASONE	4 mg/1

OpenFDA Data

• SPL SET ID: f8d52954-be1d-45d3-9245-ff2e3e81a8ac
• Manufacturer:
  • Pragma Pharmaceuticals, LLC
• UNII:
  • 7S5I7G3JQL
• RxNorm Concept Unique ID - RxCUI:
  • 343033
  • 197582
  • 197583
  • 343040
  • 197577
  • 105392
  • 205712
  • 205717
• UPC Code:
  • 0358463015018
  • 0358463014011
  • 0358463016015
  • 0358463017012

Pharmacological Class

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

NDC Crossover Matching brand name "Decadron" or generic name "Dexamethasone"

NDC	Brand Name	Generic Name
58463-016	Decadron	Decadron
58463-017	Decadron	Decadron
58463-014	Decadron	Decadron
58463-015	Decadron	Decadron
58463-010	Decadron	Decadron
0054-3177	Dexamethasone	Dexamethasone
0054-4179	Dexamethasone	Dexamethasone
0054-4180	Dexamethasone	Dexamethasone
0054-4181	Dexamethasone	Dexamethasone
0054-4182	Dexamethasone	Dexamethasone
0054-4183	Dexamethasone	Dexamethasone
0054-4184	Dexamethasone	Dexamethasone
0054-4186	Dexamethasone	Dexamethasone
0054-8174	Dexamethasone	Dexamethasone
0023-3348	OZURDEX	dexamethasone