NDC 43063-968

PredniSONE

Prednisone

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

Product ID43063-968_86465a67-8fed-ed8f-e053-2991aa0ad4eb
NDC43063-968
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1972-04-21
Marketing CategoryANDA / ANDA
Application NumberANDA080352
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NamePREDNISONE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-968-21

21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21)
Marketing Start Date2019-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-968-55 [43063096855]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-11

NDC 43063-968-21 [43063096821]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-09

NDC 43063-968-30 [43063096830]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA080352
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-16

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE5 mg/1

OpenFDA Data

SPL SET ID:f4500eb6-d24a-4247-83f4-99e73346e328
Manufacturer
UNII

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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