NDC 50090-0561

Prednisolone Acetate

Prednisolone Acetate

Prednisolone Acetate is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Prednisolone Acetate.

Product ID50090-0561_2c710885-2319-4285-919d-74cd8508ea19
NDC50090-0561
Product TypeHuman Prescription Drug
Proprietary NamePrednisolone Acetate
Generic NamePrednisolone Acetate
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1994-12-15
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA017469
Labeler NameA-S Medication Solutions
Substance NamePREDNISOLONE ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50090-0561-0

1 BOTTLE, PLASTIC in 1 CARTON (50090-0561-0) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2016-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-0561-0 [50090056100]

Prednisolone Acetate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-06-29

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:48d8fd35-51e7-4592-b901-46dd7e8e32b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1376336

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    50090-0559Prednisolone AcetatePrednisolone Acetate
    50090-0561Prednisolone AcetatePrednisolone Acetate
    50090-1912PREDNISOLONE ACETATEprednisolone acetate
    50090-5275PREDNISOLONE ACETATEprednisolone acetate
    52959-265PREDNISOLONE ACETATEprednisolone acetate
    60758-119PREDNISOLONE ACETATEprednisolone acetate
    61314-637Prednisolone AcetatePrednisolone Acetate
    68071-1722PREDNISOLONE ACETATEprednisolone acetate
    68071-2222PREDNISOLONE ACETATEprednisolone acetate
    72189-055PREDNISOLONE ACETATEPREDNISOLONE ACETATE
    76420-204PREDNISOLONE ACETATEprednisolone acetate
    51672-1338Flo-PredPrednisolone Acetate
    0065-0638OMNIPREDprednisolone acetate
    11980-180PRED FORTEprednisolone acetate
    11980-174PRED MILDprednisolone acetate
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