NDC 68791-104

PEDIAPRED

Prednisolone Sodium Phosphate

PEDIAPRED is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Royal Pharmaceuticals. The primary component is Prednisolone Sodium Phosphate.

Product ID68791-104_115a55f2-1239-4a84-aced-4546fe6e0655
NDC68791-104
Product TypeHuman Prescription Drug
Proprietary NamePEDIAPRED
Generic NamePrednisolone Sodium Phosphate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-02-07
Marketing CategoryNDA / NDA
Application NumberNDA019157
Labeler NameRoyal Pharmaceuticals
Substance NamePREDNISOLONE SODIUM PHOSPHATE
Active Ingredient Strength5 mg/5mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68791-104-04

120 mL in 1 BOTTLE (68791-104-04)
Marketing Start Date2018-02-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68791-104-04 [68791010404]

PEDIAPRED SOLUTION
Marketing CategoryNDA
Application NumberNDA019157
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-07

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE SODIUM PHOSPHATE5 mg/5mL

OpenFDA Data

SPL SET ID:1b996564-a777-4d37-ae00-b6a5ffc5e596
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312614
  • 260409

    • Pharmacological Class

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

    NDC Crossover Matching brand name "PEDIAPRED" or generic name "Prednisolone Sodium Phosphate"

    NDCBrand NameGeneric Name
    68791-104PEDIAPREDPEDIAPRED
    23594-510MillipredPREDNISOLONE SODIUM PHOSPHATE
    59212-700Orapredprednisolone sodium phosphate
    0121-0759Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    0121-0773Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    0121-0777Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    0121-0902Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    11695-1431Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATE
    13925-166Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    13985-025PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE
    17856-0759Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    24208-715PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE
    42254-102Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    42799-812Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    42799-813Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    50090-0955Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    50090-1411Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    50090-1582Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    50383-040Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    50436-0759Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate
    0178-0582Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium Phosphate
    44523-182Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium Phosphate
    23594-915Veripred 20PREDNISOLONE SODIUM PHOSPHATE

    Trademark Results [PEDIAPRED]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEDIAPRED
    PEDIAPRED
    73630356 1457972 Live/Registered
    FISONS CORPORATION
    1986-11-14
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