NDC 68788-7453

PredniSONE

Prednisone

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

Product ID68788-7453_f4a06f2a-93a4-43a7-af7b-b4061ac08aa6
NDC68788-7453
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-02-13
Marketing CategoryANDA / ANDA
Application NumberANDA087342
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NamePREDNISONE
Active Ingredient Strength20 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68788-7453-0

9 TABLET in 1 BOTTLE, PLASTIC (68788-7453-0)
Marketing Start Date2019-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7453-8 [68788745308]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-9 [68788745309]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-2 [68788745302]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-4 [68788745304]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-1 [68788745301]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-3 [68788745303]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-7 [68788745307]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-6 [68788745306]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

NDC 68788-7453-0 [68788745300]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-27

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE20 mg/1

OpenFDA Data

SPL SET ID:f4a06f2a-93a4-43a7-af7b-b4061ac08aa6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312615

    • 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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