NDC 10544-093

PredniSONE

Prednisone

PredniSONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Prednisone.

Product ID10544-093_116acf2b-e611-0e90-e054-00144ff88e88
NDC10544-093
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA084122
Labeler NameBlenheim Pharmacal, Inc.
Substance NamePREDNISONE
Active Ingredient Strength10 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-093-42

42 TABLET in 1 BOTTLE, PLASTIC (10544-093-42)
Marketing Start Date2013-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-093-42 [10544009342]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084122
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE10 mg/1

OpenFDA Data

SPL SET ID:116acf2b-e610-0e90-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312615
  • 198145
    • UPC Code
  • 0310544125108
  • 0310544125153
  • 0310544125306
  • 0310544093421

    • Pharmacological Class

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

    NDC Crossover Matching brand name "PredniSONE" or generic name "Prednisone"

    NDCBrand NameGeneric Name
    0054-0017PredniSONEPredniSONE
    0054-0018PredniSONEPredniSONE
    0054-0019PredniSONEPredniSONE
    0054-3722PredniSONEPredniSONE
    0054-4728PredniSONEPredniSONE
    0054-4741PredniSONEPredniSONE
    68071-1777PrednisonePrednisone
    68071-1779PrednisonePrednisone
    68071-3143PrednisonePrednisone
    68071-4319PrednisonePrednisone
    68071-4546PrednisonePrednisone
    68071-4685PrednisonePrednisone
    68071-4691PrednisonePrednisone
    68071-4491PrednisonePrednisone
    68151-0820PredniSONEPredniSONE
    0440-8167PrednisonePrednisone
    0440-8165PrednisonePrednisone
    0463-6155PredniSONEPredniSONE
    68258-3013PrednisonePrednisone
    0463-6141PredniSONEPredniSONE
    68387-240PrednisonePrednisone
    68387-241PrednisonePrednisone
    68788-6440PrednisonePrednisone
    68788-6414PrednisonePrednisone
    68788-7281PrednisonePrednisone
    68788-7372PrednisonePrednisone
    68788-9309PrednisonePrednisone
    68788-9178PrednisonePrednisone
    68788-9551PrednisonePrednisone
    0054-4742PredniSONEPredniSONE
    0054-8739PredniSONEPredniSONE
    0054-8724PredniSONEPredniSONE
    0054-8740PredniSONEPredniSONE
    70518-0305PrednisonePrednisone
    70518-0307PrednisonePrednisone
    70518-0205PrednisonePrednisone
    70518-0306PredniSONEPredniSONE
    70518-0242PrednisonePrednisone
    70518-0073PrednisonePrednisone
    70518-0473PrednisonePrednisone
    70518-0632PrednisonePrednisone
    70518-1116PredniSONEPredniSONE
    70518-1167PrednisonePrednisone
    70518-0948PrednisonePrednisone
    70518-0800PrednisonePrednisone
    70518-1105PredniSONEPredniSONE
    70518-1119PrednisonePrednisone
    70518-1120PrednisonePrednisone
    0591-5442PrednisonePrednisone
    70518-1854PrednisonePrednisone
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