NDC 68071-1722

PREDNISOLONE ACETATE

Prednisolone Acetate

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

Product ID68071-1722_549c7037-9583-068b-e054-00144ff8d46c
NDC68071-1722
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 NameNuCare Pharmaceuticals,Inc.
Substance NamePREDNISOLONE ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1722-5

5 mL in 1 BOX (68071-1722-5)
Marketing Start Date2017-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1722-5 [68071172205]

PREDNISOLONE ACETATE SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA017011
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-18
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:549c7037-9582-068b-e054-00144ff8d46c
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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