NDC 53217-193

Prednisolone

Prednisolone

Prednisolone is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Prednisolone.

Product ID53217-193_7d392866-ceb6-4c51-a581-27e0fb27c17e
NDC53217-193
Product TypeHuman Prescription Drug
Proprietary NamePrednisolone
Generic NamePrednisolone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2003-02-27
Marketing CategoryANDA / ANDA
Application NumberANDA040401
Labeler NameAidarex Pharmaceuticals LLC
Substance NamePREDNISOLONE
Active Ingredient Strength15 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-193-01

1 BOTTLE in 1 CARTON (53217-193-01) > 240 mL in 1 BOTTLE
Marketing Start Date2003-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-193-01 [53217019301]

Prednisolone SOLUTION
Marketing CategoryANDA
Application NumberANDA040401
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-02-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE15 mg/5mL

OpenFDA Data

SPL SET ID:fd5a9d06-81ca-4f26-86de-4b1bda6e86be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283077

    • 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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