NDC 24208-507

Lotemax SM

Loteprednol Etabonate

Lotemax SM is a Ophthalmic Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Loteprednol Etabonate.

Product ID24208-507_3cf15719-d911-4dda-be1e-6cea35831743
NDC24208-507
Product TypeHuman Prescription Drug
Proprietary NameLotemax SM
Generic NameLoteprednol Etabonate
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-02-25
Marketing CategoryNDA / NDA
Application NumberNDA208219
Labeler NameBausch & Lomb Incorporated
Substance NameLOTEPREDNOL ETABONATE
Active Ingredient Strength4 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 24208-507-01

1 BOTTLE in 1 CARTON (24208-507-01) > .5 g in 1 BOTTLE
Marketing Start Date2019-02-25
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 24208-507-07 [24208050707]

Lotemax SM GEL
Marketing CategoryNDA
Application NumberNDA208219
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-02-25

NDC 24208-507-02 [24208050702]

Lotemax SM GEL
Marketing CategoryNDA
Application NumberNDA208219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-25

NDC 24208-507-01 [24208050701]

Lotemax SM GEL
Marketing CategoryNDA
Application NumberNDA208219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-25

Drug Details

Active Ingredients

IngredientStrength
LOTEPREDNOL ETABONATE3.8 mg/g

OpenFDA Data

SPL SET ID:6f9477b5-699f-4d3b-b9a6-0cc238266237
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2118537
  • 2118539
  • Pharmacological Class

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

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

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

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