NDC 63629-4562

PredniSONE

Prednisone

PredniSONE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Prednisone.

Product ID63629-4562_00c7a5e2-742e-410b-827a-0cacf6e0d7cb
NDC63629-4562
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA084283
Labeler NameBryant Ranch Prepack
Substance NamePREDNISONE
Active Ingredient Strength50 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-4562-1

90 TABLET in 1 BOTTLE (63629-4562-1)
Marketing Start Date2011-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-4562-4 [63629456204]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-5 [63629456205]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-6 [63629456206]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-7 [63629456207]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-3 [63629456203]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-2 [63629456202]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

NDC 63629-4562-1 [63629456201]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA084283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-12
Marketing End Date2019-06-12

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE50 mg/1

OpenFDA Data

SPL SET ID:7da4f0d2-a811-4c4c-9667-242cef340917
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312615
  • 198148
  • 312617
  • 198145

    • 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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