NDC 63629-8119

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 ID63629-8119_2bca579a-a3e1-40d2-8762-d01f1c840ebd
NDC63629-8119
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1972-04-21
Marketing CategoryANDA / ANDA
Application NumberANDA080352
Labeler NameBryant Ranch Prepack
Substance NamePREDNISONE
Active Ingredient Strength5 mg/1
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63629-8119-1

5 TABLET in 1 BOTTLE (63629-8119-1)
Marketing Start Date2019-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8119-2 [63629811902]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 63629-8119-1 [63629811901]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 63629-8119-3 [63629811903]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE5 mg/1

OpenFDA Data

SPL SET ID:7da4f0d2-a811-4c4c-9667-242cef340917
Manufacturer
UNII

Pharmacological Class

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