NDC 70518-1105

PredniSONE

Prednisone

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

Product ID70518-1105_7b0bf9c2-12c6-1105-e053-2991aa0a67d8
NDC70518-1105
Product TypeHuman Prescription Drug
Proprietary NamePredniSONE
Generic NamePrednisone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-10
Marketing CategoryANDA / ANDA
Application NumberANDA087342
Labeler NameREMEDYREPACK INC.
Substance NamePREDNISONE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1105-3

14 TABLET in 1 BOTTLE, PLASTIC (70518-1105-3)
Marketing Start Date2018-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1105-2 [70518110502]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-15

NDC 70518-1105-1 [70518110501]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-11

NDC 70518-1105-4 [70518110504]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

NDC 70518-1105-3 [70518110503]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-19

NDC 70518-1105-0 [70518110500]

PredniSONE TABLET
Marketing CategoryANDA
Application NumberANDA087342
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-10

Drug Details

Active Ingredients

IngredientStrength
PREDNISONE20 mg/1

OpenFDA Data

SPL SET ID:104b26a4-feb6-4eb5-a84f-a774c41de4cb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312615

    • 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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