NDC 0065-0638

OMNIPRED

Prednisolone Acetate

OMNIPRED is a Ophthalmic Suspension in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Prednisolone Acetate.

Product ID0065-0638_00c60dec-b63c-43ac-9f87-88aeff333136
NDC0065-0638
Product TypeHuman Prescription Drug
Proprietary NameOMNIPRED
Generic NamePrednisolone Acetate
Dosage FormSuspension
Route of AdministrationOPHTHALMIC
Marketing Start Date2007-11-06
Marketing End Date2021-05-31
Marketing CategoryNDA / NDA
Application NumberNDA017469
Labeler NameAlcon Laboratories, Inc.
Substance NamePREDNISOLONE ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0065-0638-25

10 mL in 1 BOTTLE, PLASTIC (0065-0638-25)
Marketing Start Date2007-11-06
Marketing End Date2021-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0638-25 [00065063825]

OMNIPRED SUSPENSION
Marketing CategoryNDA
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-11-06
Marketing End Date2021-05-31

NDC 0065-0638-27 [00065063827]

OMNIPRED SUSPENSION
Marketing CategoryNDA
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-11-06

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:4bbb4356-b4b3-4497-a3a3-8f4b65d326fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1548714
  • 1376336

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0065-0638OMNIPREDprednisolone acetate
    51672-1338Flo-PredPrednisolone Acetate
    11980-180PRED FORTEprednisolone acetate
    11980-174PRED MILDprednisolone acetate
    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

    Trademark Results [OMNIPRED]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OMNIPRED
    OMNIPRED
    78544584 3469323 Live/Registered
    NOVARTIS AG
    2005-01-10
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