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Last Updated: December 16, 2025

List of Excipients in API roflumilast


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Excipients in NDA-approved (novel) drugs containing roflumilast

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
AstraZeneca Pharmaceuticals LP DALIRESP roflumilast 0310-0095 LACTOSE MONOHYDRATE
AstraZeneca Pharmaceuticals LP DALIRESP roflumilast 0310-0095 MAGNESIUM STEARATE
AstraZeneca Pharmaceuticals LP DALIRESP roflumilast 0310-0095 POVIDONE
AstraZeneca Pharmaceuticals LP DALIRESP roflumilast 0310-0095 STARCH, CORN
Arcutis Biotherapeutics Inc ZORYVE roflumilast 80610-130 CETEARETH-10 PHOSPHATE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing roflumilast

Company Ingredient NDC Excipient
Mylan Pharmaceuticals Inc roflumilast 0378-1905 CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc roflumilast 0378-1905 CROSCARMELLOSE SODIUM
Mylan Pharmaceuticals Inc roflumilast 0378-1905 HYDROXYPROPYL CELLULOSE
Mylan Pharmaceuticals Inc roflumilast 0378-1905 LACTOSE MONOHYDRATE
Mylan Pharmaceuticals Inc roflumilast 0378-1905 MAGNESIUM STEARATE
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for roflumilast

Excipient focus: BUTANE

Excipient focus: CARBOXYMETHYLCELLULOSE CALCIUM

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CETEARETH-10 PHOSPHATE

Excipient focus: CETEARYL PHOSPHATE

Excipient focus: CETOSTEARYL ALCOHOL

Excipient focus: COPOVIDONE K25-31

Excipient focus: CROSCARMELLOSE SODIUM

Excipient focus: DIETHYLENE GLYCOL MONOETHYL ETHER

Excipient focus: HEXYLENE GLYCOL

Excipient focus: HYDROCHLORIC ACID

Excipient focus: HYDROXYPROPYL CELLULOSE

Excipient focus: HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Excipient focus: HYPROMELLOSE 2910

Excipient focus: ISOBUTANE

Excipient focus: ISOPROPYL PALMITATE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: MAGNESIUM STEARATE

Excipient focus: MANNITOL

Excipient focus: METHYLENE CHLORIDE

Excipient focus: METHYLPARABEN

Excipient focus: MICROCRYSTALLINE CELLULOSE 102

Excipient focus: POLOXAMER 188

Excipient focus: POLOXAMER 407

Excipient focus: POLYSORBATE 80

Excipient focus: POLYVINYL ALCOHOL

Excipient focus: POVIDONE

Excipient focus: PROPANE

Excipient focus: PROPYLPARABEN

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM HYDROXIDE

Excipient focus: SODIUM STEARYL FUMARATE

Excipient focus: STARCH, CORN

Excipient focus: WATER

Excipient focus: WHITE PETROLATUM

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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