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Last Updated: December 11, 2025

List of Excipients in API loteprednol etabonate

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Excipients in NDA-approved (novel) drugs containing loteprednol etabonate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
STAT Rx USA LLC	ALREX	loteprednol etabonate	16590-007	BENZALKONIUM CHLORIDE
STAT Rx USA LLC	ALREX	loteprednol etabonate	16590-007	EDETATE DISODIUM
STAT Rx USA LLC	ALREX	loteprednol etabonate	16590-007	GLYCERIN
STAT Rx USA LLC	ALREX	loteprednol etabonate	16590-007	HYDROCHLORIC ACID
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing loteprednol etabonate

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Company	Ingredient	NDC	Excipient
Akorn	loteprednol etabonate	17478-830	BENZALKONIUM CHLORIDE
Akorn	loteprednol etabonate	17478-830	BORIC ACID
Akorn	loteprednol etabonate	17478-830	EDETATE DISODIUM
Akorn	loteprednol etabonate	17478-830	GLYCERIN
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for loteprednol etabonate

Excipient focus: BENZALKONIUM CHLORIDE

loteprednol etabonate drug variants containing BENZALKONIUM CHLORIDE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing BENZALKONIUM CHLORIDE

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
Physicians Total Care Inc	loteprednol etabonate	54868-4278
ALCON LABORATORIES INC	loteprednol etabonate	71571-121
>Company	>Ingredient	>NDC

Excipient focus: BORIC ACID

loteprednol etabonate drug variants containing BORIC ACID

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
Bausch & Lomb Incorporated	loteprednol etabonate	24208-508
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing BORIC ACID

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: CITRIC ACID MONOHYDRATE

loteprednol etabonate drug variants containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
ALCON LABORATORIES INC	loteprednol etabonate	71571-121
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: EDETATE DISODIUM

loteprednol etabonate drug variants containing EDETATE DISODIUM

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing EDETATE DISODIUM

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: GLYCERIN

loteprednol etabonate drug variants containing GLYCERIN

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing GLYCERIN

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

loteprednol etabonate drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Akorn	loteprednol etabonate	50383-265
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE

loteprednol etabonate drug variants containing HYPROMELLOSE

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing HYPROMELLOSE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: MINERAL OIL

loteprednol etabonate drug variants containing MINERAL OIL

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing MINERAL OIL

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: PETROLATUM

loteprednol etabonate drug variants containing PETROLATUM

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing PETROLATUM

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: POLOXAMER 407

loteprednol etabonate drug variants containing POLOXAMER 407

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing POLOXAMER 407

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: POLYCARBOPHIL

loteprednol etabonate drug variants containing POLYCARBOPHIL

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
Bausch & Lomb Incorporated	loteprednol etabonate	24208-508
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing POLYCARBOPHIL

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE

loteprednol etabonate drug variants containing POVIDONE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Physicians Total Care Inc	loteprednol etabonate	54868-4277
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing POVIDONE

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K30

loteprednol etabonate drug variants containing POVIDONE K30

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	50383-265
ARMAS PHARMACEUTICALS INC	loteprednol etabonate	72485-653
ARMAS PHARMACEUTICALS INC	loteprednol etabonate	72485-665
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing POVIDONE K30

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K90

loteprednol etabonate drug variants containing POVIDONE K90

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Company	Ingredient	NDC
Amneal Pharmaceuticals NY LLC	loteprednol etabonate	60219-1366
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing POVIDONE K90

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

loteprednol etabonate drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
Bausch & Lomb Incorporated	loteprednol etabonate	24208-508
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

loteprednol etabonate drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-503
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
Bausch & Lomb Incorporated	loteprednol etabonate	24208-508
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

loteprednol etabonate drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
ALCON LABORATORIES INC	loteprednol etabonate	71571-121
>Company	>Ingredient	>NDC

Excipient focus: SULFURIC ACID

loteprednol etabonate drug variants containing SULFURIC ACID

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate and tobramycin	24208-358
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing SULFURIC ACID

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: TRISODIUM CITRATE DIHYDRATE

loteprednol etabonate drug variants containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
ALCON LABORATORIES INC	loteprednol etabonate	71571-121
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

Excipient focus: TYLOXAPOL

loteprednol etabonate drug variants containing TYLOXAPOL

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing TYLOXAPOL

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
Bausch & Lomb Incorporated	loteprednol etabonate	24208-507
ALCON LABORATORIES INC	loteprednol etabonate	71571-121
>Company	>Ingredient	>NDC

Excipient focus: WATER

loteprednol etabonate drug variants containing WATER

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Company	Ingredient	NDC
STAT Rx USA LLC	loteprednol etabonate	16590-007
Akorn	loteprednol etabonate	17478-830
Bausch & Lomb Incorporated	loteprednol etabonate	24208-299
Bausch & Lomb Incorporated	loteprednol etabonate	24208-353
>Company	>Ingredient	>NDC

loteprednol etabonate drug variants not containing WATER

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Company	Ingredient	NDC
Bausch & Lomb Incorporated	loteprednol etabonate	24208-443
>Company	>Ingredient	>NDC

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