NDC 60758-119

PREDNISOLONE ACETATE

Prednisolone Acetate

PREDNISOLONE ACETATE is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Pacific Pharma, Inc.. The primary component is Prednisolone Acetate.

Product ID60758-119_35214d98-7151-405f-804e-13101e4253dc
NDC60758-119
Product TypeHuman Prescription Drug
Proprietary NamePREDNISOLONE ACETATE
Generic NamePrednisolone Acetate
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1997-08-19
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA017011
Labeler NamePacific Pharma, Inc.
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 60758-119-05

1 BOTTLE, DROPPER in 1 CARTON (60758-119-05) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date1997-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60758-119-10 [60758011910]

PREDNISOLONE ACETATE SUSPENSION/ DROPS
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA017011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-08-19

NDC 60758-119-05 [60758011905]

PREDNISOLONE ACETATE SUSPENSION/ DROPS
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA017011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-08-19

NDC 60758-119-15 [60758011915]

PREDNISOLONE ACETATE SUSPENSION/ DROPS
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA017011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-08-19

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:1474d1df-70b6-4b1e-86d1-3349aa6d42fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1376336
  • Pharmacological Class

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

    Medicade Reported Pricing

    60758011915 PREDNISOLONE AC 1% EYE DROP

    Pricing Unit: ML | Drug Type:

    60758011910 PREDNISOLONE AC 1% EYE DROP

    Pricing Unit: ML | Drug Type:

    60758011905 PREDNISOLONE AC 1% EYE DROP

    Pricing Unit: ML | Drug Type:

    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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