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Last Updated: December 22, 2024

List of Excipients in API montelukast


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Excipients in NDA-approved (novel) drugs containing montelukast

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
Merck Sharp & Dohme Corp SINGULAIR montelukast sodium 0006-3841 HYDROXYPROPYL CELLULOSE
Merck Sharp & Dohme Corp SINGULAIR montelukast sodium 0006-3841 MAGNESIUM STEARATE
Merck Sharp & Dohme Corp SINGULAIR montelukast sodium 0006-3841 MANNITOL
Rebel Distributors Corp SINGULAIR montelukast sodium 21695-565 ASPARTAME
Rebel Distributors Corp SINGULAIR montelukast sodium 21695-565 CELLULOSE, MICROCRYSTALLINE
Rebel Distributors Corp SINGULAIR montelukast sodium 21695-565 CROSCARMELLOSE SODIUM
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing montelukast

Company Ingredient NDC Excipient
West ward Pharmaceutical Corp montelukast 0143-9649 CARNAUBA WAX
West ward Pharmaceutical Corp montelukast 0143-9649 CELLULOSE, MICROCRYSTALLINE
West ward Pharmaceutical Corp montelukast 0143-9649 CROSCARMELLOSE SODIUM
West ward Pharmaceutical Corp montelukast 0143-9649 FERRIC OXIDE RED
West ward Pharmaceutical Corp montelukast 0143-9649 FERRIC OXIDE YELLOW
West ward Pharmaceutical Corp montelukast 0143-9649 HYDROXYPROPYL CELLULOSE
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for montelukast

Excipient focus: ASPARTAME

Excipient focus: BUTYLATED HYDROXYANISOLE

Excipient focus: CARNAUBA WAX

Excipient focus: CELLULOSE, MICROCRYSTALLINE

montelukast drug variants not containing CELLULOSE, MICROCRYSTALLINE

Company Ingredient NDC
International Laboratories LLC montelukast 54458-890
Merck Sharp & Dohme Corp montelukast sodium 0006-3841
Teva Pharmaceuticals USA Inc montelukast sodium 0093-7426
Teva Pharmaceuticals USA Inc montelukast sodium 0093-7487
NCS HealthCare of KY Inc dba Vangard Labs montelukast sodium 0615-7748
Accord Healthcare Inc montelukast sodium 16729-119
>Company >Ingredient >NDC

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Excipient focus: CHERRY

Excipient focus: COLLOIDAL SILICON DIOXIDE

Excipient focus: CROSCARMELLOSE SODIUM

montelukast drug variants not containing CROSCARMELLOSE SODIUM

Company Ingredient NDC
International Laboratories LLC montelukast 54458-890
Merck Sharp & Dohme Corp montelukast sodium 0006-3841
Hikma Pharmaceuticals USA Inc montelukast sodium 0054-0259
Teva Pharmaceuticals USA Inc montelukast sodium 0093-7426
Teva Pharmaceuticals USA Inc montelukast sodium 0093-7487
NCS HealthCare of KY Inc dba Vangard Labs montelukast sodium 0615-7748
>Company >Ingredient >NDC

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Excipient focus: EDETATE DISODIUM

Excipient focus: FERRIC OXIDE RED

Excipient focus: FERRIC OXIDE YELLOW

Excipient focus: FERROSOFERRIC OXIDE

Excipient focus: HYDROXYPROPYL CELLULOSE

montelukast drug variants not containing HYDROXYPROPYL CELLULOSE

Company Ingredient NDC
Amneal Pharmaceuticals LLC montelukast 65162-732
Amneal Pharmaceuticals LLC montelukast 65162-771
Hikma Pharmaceuticals USA Inc montelukast sodium 0054-0259
NCS HealthCare of KY Inc dba Vangard Labs montelukast sodium 0615-7983
Torrent Pharmaceuticals Limited montelukast sodium 13668-079
PD-Rx Pharmaceuticals Inc montelukast sodium 43063-381
>Company >Ingredient >NDC

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Excipient focus: HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Excipient focus: HYPROMELLOSE

Excipient focus: HYPROMELLOSE 2208

montelukast drug variants containing HYPROMELLOSE 2208

Company Ingredient NDC
State of Florida DOH Central Pharmacy montelukast sodium 53808-0690
State of Florida DOH Central Pharmacy montelukast sodium 53808-0995
ReadyMeds montelukast sodium 64205-655
Strides Pharma Science Limited montelukast sodium 64380-256
Carilion Materials Management montelukast sodium 68151-3494
Carilion Materials Management montelukast sodium 68151-3498
>Company >Ingredient >NDC

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Excipient focus: HYPROMELLOSE 2910

Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LACTOSE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: MAGNESIUM STEARATE

Excipient focus: MALTODEXTRIN

Excipient focus: MANNITOL

Excipient focus: MICROCRYSTALLINE CELLULOSE 112

Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYETHYLENE GLYCOL 3350

Excipient focus: POLYETHYLENE GLYCOL 400

Excipient focus: POLYETHYLENE GLYCOL 6000

Excipient focus: POLYETHYLENE GLYCOLS

Excipient focus: POLYVINYL ALCOHOL

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM LAURYL SULFATE

Excipient focus: SODIUM PHOSPHATE, TRIBASIC

Excipient focus: SODIUM STARCH GLYCOLATE TYPE A POTATO

montelukast drug variants containing SODIUM STARCH GLYCOLATE TYPE A POTATO

Company Ingredient NDC
International Laboratories LLC montelukast 54458-890
Hikma Pharmaceuticals USA Inc montelukast sodium 0054-0259
Teva Pharmaceuticals USA Inc montelukast sodium 0093-7426
NCS HealthCare of KY Inc dba Vangard Labs montelukast sodium 0615-7748
NCS HealthCare of KY Inc dba Vangard Labs montelukast sodium 0615-7983
QPharma Inc montelukast sodium 42708-042
>Company >Ingredient >NDC

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Excipient focus: SODIUM STEARYL FUMARATE

Excipient focus: STARCH, CORN

Excipient focus: SUCRALOSE

Excipient focus: TALC

Excipient focus: TITANIUM DIOXIDE

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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