NDC 63187-466

Prednisolone

Prednisolone

Prednisolone is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Prednisolone.

Product ID63187-466_387169e5-fdc7-4bd8-94f5-ce71571dd90e
NDC63187-466
Product TypeHuman Prescription Drug
Proprietary NamePrednisolone
Generic NamePrednisolone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2003-02-27
Marketing CategoryANDA / ANDA
Application NumberANDA040401
Labeler NameProficient Rx LP
Substance NamePREDNISOLONE
Active Ingredient Strength15 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63187-466-64

1 BOTTLE in 1 CARTON (63187-466-64) > 240 mL in 1 BOTTLE
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-466-64 [63187046664]

Prednisolone SOLUTION
Marketing CategoryANDA
Application NumberANDA040401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE15 mg/5mL

OpenFDA Data

SPL SET ID:246703b1-a792-4653-a391-02d3c6212cb7
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.