NDC 0054-3721

PredniSONE Intensol

Prednisone Intensol

PredniSONE Intensol is a Oral Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Prednisone.

• Product ID: 0054-3721_114e22f8-b459-47c6-aa0f-5bf096f924d6
• NDC: 0054-3721
• Product Type: Human Prescription Drug
• Proprietary Name: PredniSONE Intensol
• Generic Name: Prednisone Intensol
• Dosage Form: Solution, Concentrate
• Route of Administration: ORAL
• Marketing Start Date: 1985-02-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088810
• Labeler Name: Hikma Pharmaceuticals USA Inc.
• Substance Name: PREDNISONE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0054-3721-44

30 mL in 1 BOTTLE, GLASS (0054-3721-44)

• Marketing Start Date: 1985-02-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-3721-44 [00054372144]

PredniSONE Intensol SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA088810
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-02-20

Drug Details

Active Ingredients

Ingredient	Strength
PREDNISONE	5 mg/mL

OpenFDA Data

• SPL SET ID: 3115aef0-fd50-4ec8-a064-3effb695f3f2
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • VB0R961HZT
• RxNorm Concept Unique ID - RxCUI:
  • 198145
  • 198144
  • 198146
  • 312615
  • 198148
  • 312617
  • 205301
  • 795858
  • 315187
• UPC Code:
  • 0300540018252
  • 0300543722507
  • 0300544741255
  • 0300548724254
  • 0300540017255
  • 0300544728256
  • 0300548739258
  • 0300544742252
  • 0300548740254
  • 0300540019259

Pharmacological Class

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