NDC 0603-1567

PrednisoLONE

Prednisolone

PrednisoLONE is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Prednisolone.

Product ID0603-1567_5aad3237-1f8b-48f7-bac1-9d30c2cccbb3
NDC0603-1567
Product TypeHuman Prescription Drug
Proprietary NamePrednisoLONE
Generic NamePrednisolone
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2007-09-21
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA040775
Labeler NamePar Pharmaceutical
Substance NamePREDNISOLONE
Active Ingredient Strength15 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0603-1567-58

480 mL in 1 BOTTLE (0603-1567-58)
Marketing Start Date2007-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-1567-56 [00603156756]

PrednisoLONE SYRUP
Marketing CategoryANDA
Application NumberANDA040775
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-09-21
Marketing End Date2019-05-31

NDC 0603-1567-58 [00603156758]

PrednisoLONE SYRUP
Marketing CategoryANDA
Application NumberANDA040775
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-09-21
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE15 mg/5mL

OpenFDA Data

SPL SET ID:c72e764b-a3ab-4c7b-96ad-81f261feab08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283077
    • UPC Code
  • 0306031567582

    • Pharmacological Class

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

    NDC Crossover Matching brand name "PrednisoLONE" or generic name "Prednisolone"

    NDCBrand NameGeneric Name
    0527-5406PrednisoLONEPrednisolone
    0603-1567PrednisoLONEPrednisolone
    12634-686PrednisolonePrednisolone
    21695-365PrednisolonePrednisolone
    33261-475PrednisolonePrednisolone
    50090-0655PrednisolonePrednisolone
    50383-042PrednisolonePrednisolone
    53217-193PrednisolonePrednisolone
    58177-910PrednisolonePrednisolone
    61919-291PREDNISOLONEPREDNISOLONE
    62135-250PrednisolonePrednisolone oral
    63187-466PrednisolonePrednisolone
    63629-1862PrednisolonePrednisolone
    66116-603PrednisolonePrednisolone
    67296-1656PrednisolonePrednisolone
    68258-8987PrednisolonePrednisolone
    68788-7207PrednisoLONEPrednisolone
    68788-9096PrednisolonePrednisolone
    70518-2084PrednisolonePrednisolone
    23594-505MILLIPREDPREDNISOLONE
    73534-505MILLIPREDPREDNISOLONE
    0378-4710Prednisolone Sodium Phosphateprednisolone
    0378-4715Prednisolone Sodium Phosphateprednisolone
    0378-4730Prednisolone Sodium Phosphateprednisolone
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