List of Excipients in API roflumilast
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Excipients in NDA-approved (novel) drugs containing roflumilast
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 | |
Arcutis Biotherapeutics Inc | ZORYVE | roflumilast | 80610-130 | CETEARYL PHOSPHATE | |
Arcutis Biotherapeutics Inc | ZORYVE | roflumilast | 80610-130 | CETOSTEARYL ALCOHOL | |
>Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing roflumilast
Detailed excipient profiles for roflumilast
Excipient focus: BUTANE
roflumilast drug variants containing BUTANE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing BUTANE
Excipient focus: CARBOXYMETHYLCELLULOSE CALCIUM
roflumilast drug variants containing CARBOXYMETHYLCELLULOSE CALCIUM
Company | Ingredient | NDC |
---|---|---|
Torrent Pharmaceuticals Limited | roflumilast | 13668-476 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CARBOXYMETHYLCELLULOSE CALCIUM
Excipient focus: CELLULOSE, MICROCRYSTALLINE
roflumilast drug variants containing CELLULOSE, MICROCRYSTALLINE
Company | Ingredient | NDC |
---|---|---|
Mylan Pharmaceuticals Inc | roflumilast | 0378-1905 |
Zydus Pharmaceuticals USA Inc | roflumilast | 68382-969 |
Zydus Lifesciences Limited | roflumilast | 70771-1674 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: CETEARETH-10 PHOSPHATE
roflumilast drug variants containing CETEARETH-10 PHOSPHATE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CETEARETH-10 PHOSPHATE
Excipient focus: CETEARYL PHOSPHATE
roflumilast drug variants containing CETEARYL PHOSPHATE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CETEARYL PHOSPHATE
Excipient focus: CETOSTEARYL ALCOHOL
roflumilast drug variants containing CETOSTEARYL ALCOHOL
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CETOSTEARYL ALCOHOL
Excipient focus: COPOVIDONE K25-31
roflumilast drug variants containing COPOVIDONE K25-31
Company | Ingredient | NDC |
---|---|---|
Solco Healthcare US LLC | roflumilast | 43547-005 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing COPOVIDONE K25-31
Excipient focus: CROSCARMELLOSE SODIUM
roflumilast drug variants containing CROSCARMELLOSE SODIUM
Company | Ingredient | NDC |
---|---|---|
Mylan Pharmaceuticals Inc | roflumilast | 0378-1905 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: DIETHYLENE GLYCOL MONOETHYL ETHER
roflumilast drug variants containing DIETHYLENE GLYCOL MONOETHYL ETHER
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing DIETHYLENE GLYCOL MONOETHYL ETHER
Excipient focus: HEXYLENE GLYCOL
roflumilast drug variants containing HEXYLENE GLYCOL
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing HEXYLENE GLYCOL
Excipient focus: HYDROCHLORIC ACID
roflumilast drug variants containing HYDROCHLORIC ACID
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing HYDROCHLORIC ACID
Excipient focus: HYDROXYPROPYL CELLULOSE
roflumilast drug variants containing HYDROXYPROPYL CELLULOSE
Company | Ingredient | NDC |
---|---|---|
Mylan Pharmaceuticals Inc | roflumilast | 0378-1905 |
Micro Labs Limited | roflumilast | 42571-259 |
Solco Healthcare US LLC | roflumilast | 43547-005 |
Strides Pharma Science Limited | roflumilast | 64380-786 |
Bryant Ranch Prepack | roflumilast | 72162-2385 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing HYDROXYPROPYL CELLULOSE
Excipient focus: HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
roflumilast drug variants containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Company | Ingredient | NDC |
---|---|---|
Zydus Pharmaceuticals USA Inc | roflumilast | 68382-969 |
Zydus Lifesciences Limited | roflumilast | 70771-1674 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Excipient focus: HYPROMELLOSE 2910
roflumilast drug variants containing HYPROMELLOSE 2910
Company | Ingredient | NDC |
---|---|---|
Aurobindo Pharma Limited | roflumilast | 59651-275 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing HYPROMELLOSE 2910
Excipient focus: ISOBUTANE
roflumilast drug variants containing ISOBUTANE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing ISOBUTANE
Excipient focus: ISOPROPYL PALMITATE
roflumilast drug variants containing ISOPROPYL PALMITATE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing ISOPROPYL PALMITATE
Excipient focus: LACTOSE MONOHYDRATE
roflumilast drug variants containing LACTOSE MONOHYDRATE
roflumilast drug variants not containing LACTOSE MONOHYDRATE
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
American Health Packaging | roflumilast | 60687-786 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
Excipient focus: MAGNESIUM STEARATE
roflumilast drug variants containing MAGNESIUM STEARATE
roflumilast drug variants not containing MAGNESIUM STEARATE
Company | Ingredient | NDC |
---|---|---|
Solco Healthcare US LLC | roflumilast | 43547-005 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
Excipient focus: MANNITOL
roflumilast drug variants containing MANNITOL
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
American Health Packaging | roflumilast | 60687-786 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing MANNITOL
Excipient focus: METHYLENE CHLORIDE
roflumilast drug variants containing METHYLENE CHLORIDE
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing METHYLENE CHLORIDE
Excipient focus: METHYLPARABEN
roflumilast drug variants containing METHYLPARABEN
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing METHYLPARABEN
Excipient focus: MICROCRYSTALLINE CELLULOSE 102
roflumilast drug variants containing MICROCRYSTALLINE CELLULOSE 102
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
American Health Packaging | roflumilast | 60687-786 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing MICROCRYSTALLINE CELLULOSE 102
Excipient focus: POLOXAMER 188
roflumilast drug variants containing POLOXAMER 188
Company | Ingredient | NDC |
---|---|---|
Aurobindo Pharma Limited | roflumilast | 59651-275 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing POLOXAMER 188
Excipient focus: POLOXAMER 407
roflumilast drug variants containing POLOXAMER 407
Company | Ingredient | NDC |
---|---|---|
Zydus Pharmaceuticals USA Inc | roflumilast | 68382-969 |
Zydus Lifesciences Limited | roflumilast | 70771-1674 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing POLOXAMER 407
Excipient focus: POLYSORBATE 80
roflumilast drug variants containing POLYSORBATE 80
Company | Ingredient | NDC |
---|---|---|
MAJOR PHARMACEUTICALS | roflumilast | 0904-7399 |
MAJOR PHARMACEUTICALS | roflumilast | 0904-7483 |
Novadoz Pharmaceuticals LLC | roflumilast | 72205-200 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing POLYSORBATE 80
Excipient focus: POLYVINYL ALCOHOL
roflumilast drug variants containing POLYVINYL ALCOHOL
Company | Ingredient | NDC |
---|---|---|
Torrent Pharmaceuticals Limited | roflumilast | 13668-476 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing POLYVINYL ALCOHOL
Excipient focus: POVIDONE
roflumilast drug variants containing POVIDONE
Company | Ingredient | NDC |
---|---|---|
AstraZeneca Pharmaceuticals LP | roflumilast | 0310-0095 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing POVIDONE
Excipient focus: PROPANE
roflumilast drug variants containing PROPANE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing PROPANE
Excipient focus: PROPYLPARABEN
roflumilast drug variants containing PROPYLPARABEN
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing PROPYLPARABEN
Excipient focus: SILICON DIOXIDE
roflumilast drug variants containing SILICON DIOXIDE
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
American Health Packaging | roflumilast | 60687-786 |
Zydus Pharmaceuticals USA Inc | roflumilast | 68382-969 |
Zydus Lifesciences Limited | roflumilast | 70771-1674 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM HYDROXIDE
roflumilast drug variants containing SODIUM HYDROXIDE
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing SODIUM HYDROXIDE
Excipient focus: SODIUM STEARYL FUMARATE
roflumilast drug variants containing SODIUM STEARYL FUMARATE
Company | Ingredient | NDC |
---|---|---|
Solco Healthcare US LLC | roflumilast | 43547-005 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing SODIUM STEARYL FUMARATE
Excipient focus: STARCH, CORN
roflumilast drug variants containing STARCH, CORN
roflumilast drug variants not containing STARCH, CORN
Company | Ingredient | NDC |
---|---|---|
Camber Pharmaceuticals Inc | roflumilast | 31722-623 |
American Health Packaging | roflumilast | 60687-786 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
Excipient focus: WATER
roflumilast drug variants containing WATER
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing WATER
Excipient focus: WHITE PETROLATUM
roflumilast drug variants containing WHITE PETROLATUM
Company | Ingredient | NDC |
---|---|---|
Arcutis Biotherapeutics Inc | roflumilast | 80610-130 |
Arcutis Biotherapeutics Inc | roflumilast | 80610-430 |
>Company | >Ingredient | >NDC |
roflumilast drug variants not containing WHITE PETROLATUM
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