NDC 61314-637

Prednisolone Acetate

Prednisolone Acetate

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

Product ID61314-637_09d17d81-3127-46b9-8553-ffc22e9434a8
NDC61314-637
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 NameSandoz Inc
Substance NamePREDNISOLONE ACETATE
Active Ingredient Strength10 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 61314-637-05

1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date1994-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-637-15 [61314063715]

Prednisolone Acetate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-12-15

NDC 61314-637-10 [61314063710]

Prednisolone Acetate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-12-15

NDC 61314-637-05 [61314063705]

Prednisolone Acetate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA017469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-12-15

Drug Details

Active Ingredients

IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

OpenFDA Data

SPL SET ID:05d205c7-8f51-46b9-a6c5-4199bc432b26
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1376336
  • Pharmacological Class

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

    Medicade Reported Pricing

    61314063715 PREDNISOLONE AC 1% EYE DROP

    Pricing Unit: ML | Drug Type:

    61314063710 PREDNISOLONE AC 1% EYE DROP

    Pricing Unit: ML | Drug Type:

    61314063705 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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