NDC 68682-299

Loteprednol Etabonate

Loteprednol Etabonate

Loteprednol Etabonate is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Oceanside Pharmaceuticals. The primary component is Loteprednol Etabonate.

Product ID68682-299_3246bcdf-e795-46ef-b613-612c0105b693
NDC68682-299
Product TypeHuman Prescription Drug
Proprietary NameLoteprednol Etabonate
Generic NameLoteprednol Etabonate
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-07-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020583
Labeler NameOceanside Pharmaceuticals
Substance NameLOTEPREDNOL ETABONATE
Active Ingredient Strength5 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68682-299-05

1 BOTTLE in 1 CARTON (68682-299-05) > 5 mL in 1 BOTTLE
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-299-10 [68682029910]

Loteprednol Etabonate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA020583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-01

NDC 68682-299-15 [68682029915]

Loteprednol Etabonate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA020583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-01

NDC 68682-299-05 [68682029905]

Loteprednol Etabonate SUSPENSION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA020583
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL

OpenFDA Data

SPL SET ID:f9edfd73-e1b1-44e4-8e7c-90b0c2fa204d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311382
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Loteprednol Etabonate" or generic name "Loteprednol Etabonate"

    NDCBrand NameGeneric Name
    17478-830Loteprednol EtabonateLoteprednol Etabonate
    24208-508Loteprednol Etabonateloteprednol etabonate
    50383-265Loteprednol EtabonateLoteprednol Etabonate
    62756-232Loteprednol EtabonateLoteprednol Etabonate
    68682-299Loteprednol Etabonateloteprednol etabonate
    24208-353Alrexloteprednol etabonate
    71571-333Eysuvisloteprednol etabonate
    71571-121Inveltysloteprednol etabonate
    24208-299LOTEMAXloteprednol etabonate
    24208-443Lotemaxloteprednol etabonate
    24208-503LOTEMAXloteprednol etabonate
    24208-507Lotemax SMloteprednol etabonate

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