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Last Updated: November 22, 2024

List of Excipients in API FENTANYL


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Excipients in NDA-approved (novel) drugs containing FENTANYL

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
ProStrakan Inc ABSTRAL fentanyl 42747-221 CELLULOSE, MICROCRYSTALLINE
ProStrakan Inc ABSTRAL fentanyl 42747-221 CROSCARMELLOSE SODIUM
ProStrakan Inc ABSTRAL fentanyl 42747-221 MAGNESIUM STEARATE
ProStrakan Inc ABSTRAL fentanyl 42747-221 MANNITOL
Janssen Pharmaceuticals Inc DURAGESIC fentanyl 50458-101 ISOPROPYL MYRISTATE
Cephalon LLC FENTORA fentanyl 63459-541 ANHYDROUS CITRIC ACID
Cephalon LLC FENTORA fentanyl 63459-541 MAGNESIUM STEARATE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing FENTANYL

Company Ingredient NDC Excipient
Mylan Pharmaceuticals Inc fentanyl 0378-9119 DIMETHICONE
Mylan Pharmaceuticals Inc fentanyl 0378-9119 TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062 DIMETHICONE
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062 TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER
Quality Care Products LLC fentanyl 35356-632 DIMETHICONE
Quality Care Products LLC fentanyl 35356-632 TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634 DIMETHICONE
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for FENTANYL

Excipient focus: ALCOHOL

Excipient focus: AMMONIA

Excipient focus: ANHYDROUS CITRIC ACID

Excipient focus: CELLULOSE, MICROCRYSTALLINE

FENTANYL drug variants not containing CELLULOSE, MICROCRYSTALLINE

Company Ingredient NDC
Mylan Pharmaceuticals Inc fentanyl 0378-9119
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062
Quality Care Products LLC fentanyl 35356-632
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634
STAT Rx USA LLC fentanyl 42549-573
ALVOGEN fentanyl 47781-423
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
>Company >Ingredient >NDC

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Excipient focus: CITRIC ACID

Excipient focus: CITRIC ACID MONOHYDRATE

Excipient focus: COPOVIDONE

Excipient focus: COPOVIDONE K25-31

Excipient focus: CROSCARMELLOSE SODIUM

FENTANYL drug variants not containing CROSCARMELLOSE SODIUM

Company Ingredient NDC
Mylan Pharmaceuticals Inc fentanyl 0378-9119
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062
Quality Care Products LLC fentanyl 35356-632
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634
STAT Rx USA LLC fentanyl 42549-573
ALVOGEN fentanyl 47781-423
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
>Company >Ingredient >NDC

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Excipient focus: DEXTRATES

Excipient focus: DIMETHICONE

Excipient focus: DIMETHICONE 350

FENTANYL drug variants containing DIMETHICONE 350

Company Ingredient NDC
SpecGx LLC fentanyl transdermal 0406-9025
SpecGx LLC fentanyl transdermal 0406-9112
Rebel Distributors Corp fentanyl transdermal system 21695-975
Rebel Distributors Corp fentanyl transdermal system 42254-002
Bryant Ranch Prepack fentanyl transdermal 63629-4764
Bryant Ranch Prepack fentanyl transdermal 63629-4771
Bryant Ranch Prepack fentanyl transdermal 63629-4773
>Company >Ingredient >NDC

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Excipient focus: DIPROPYLENE GLYCOL

FENTANYL drug variants containing DIPROPYLENE GLYCOL

Company Ingredient NDC
SpecGx LLC fentanyl transdermal 0406-9025
SpecGx LLC fentanyl transdermal 0406-9112
Rebel Distributors Corp fentanyl transdermal system 21695-975
Rebel Distributors Corp fentanyl transdermal system 42254-002
Bryant Ranch Prepack fentanyl transdermal 63629-4764
Bryant Ranch Prepack fentanyl transdermal 63629-4771
Bryant Ranch Prepack fentanyl transdermal 63629-4773
>Company >Ingredient >NDC

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Excipient focus: ETHYLENE-VINYL ACETATE COPOLYMER

FENTANYL drug variants containing ETHYLENE-VINYL ACETATE COPOLYMER

Company Ingredient NDC
SpecGx LLC fentanyl transdermal 0406-9025
SpecGx LLC fentanyl transdermal 0406-9112
Rebel Distributors Corp fentanyl transdermal system 21695-975
Rebel Distributors Corp fentanyl transdermal system 42254-002
Bryant Ranch Prepack fentanyl transdermal 63629-4764
Bryant Ranch Prepack fentanyl transdermal 63629-4771
Bryant Ranch Prepack fentanyl transdermal 63629-4773
>Company >Ingredient >NDC

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Excipient focus: FD&C BLUE NO. 1

Excipient focus: HEPTANE

FENTANYL drug variants containing HEPTANE

Company Ingredient NDC
SpecGx LLC fentanyl transdermal 0406-9025
SpecGx LLC fentanyl transdermal 0406-9112
Rebel Distributors Corp fentanyl transdermal system 21695-975
Rebel Distributors Corp fentanyl transdermal system 42254-002
Bryant Ranch Prepack fentanyl transdermal 63629-4764
Bryant Ranch Prepack fentanyl transdermal 63629-4771
Bryant Ranch Prepack fentanyl transdermal 63629-4773
>Company >Ingredient >NDC

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Excipient focus: HYDROCHLORIC ACID

Excipient focus: HYDROXYPROPYL CELLULOSE

FENTANYL drug variants containing HYDROXYPROPYL CELLULOSE

Company Ingredient NDC
SpecGx LLC fentanyl transdermal 0406-9025
SpecGx LLC fentanyl transdermal 0406-9112
Bryant Ranch Prepack fentanyl transdermal 63629-4764
Bryant Ranch Prepack fentanyl transdermal 63629-4771
Bryant Ranch Prepack fentanyl transdermal 63629-4773
Rebel Distributors Corp fentanyl transdermal system 21695-975
Rebel Distributors Corp fentanyl transdermal system 42254-002
>Company >Ingredient >NDC

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Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL MYRISTATE

Excipient focus: MAGNESIUM STEARATE

FENTANYL drug variants not containing MAGNESIUM STEARATE

Company Ingredient NDC
Mylan Pharmaceuticals Inc fentanyl 0378-9119
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062
Quality Care Products LLC fentanyl 35356-632
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634
STAT Rx USA LLC fentanyl 42549-573
ALVOGEN fentanyl 47781-423
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
>Company >Ingredient >NDC

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Excipient focus: MANNITOL

FENTANYL drug variants not containing MANNITOL

Company Ingredient NDC
Mylan Pharmaceuticals Inc fentanyl 0378-9119
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062
Quality Care Products LLC fentanyl 35356-632
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634
STAT Rx USA LLC fentanyl 42549-573
ALVOGEN fentanyl 47781-423
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
>Company >Ingredient >NDC

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Excipient focus: METHYL LAURATE

FENTANYL drug variants not containing METHYL LAURATE

Company Ingredient NDC
Mylan Pharmaceuticals Inc fentanyl 0378-9119
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-062
Quality Care Products LLC fentanyl 35356-632
Lake Erie Medical DBA Quality Care Products LLC fentanyl 35356-634
STAT Rx USA LLC fentanyl 42549-573
ProStrakan Inc fentanyl 42747-221
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
>Company >Ingredient >NDC

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Excipient focus: MINERAL OIL

Excipient focus: MODIFIED CORN STARCH

Excipient focus: OCTYLDODECANOL

Excipient focus: PECTIN

Excipient focus: PHENYLETHYL ALCOHOL

Excipient focus: POLYBUTENE

Excipient focus: POLYISOBUTYLENE

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN

Excipient focus: SHELLAC

Excipient focus: SODIUM BICARBONATE

Excipient focus: SODIUM CARBONATE

Excipient focus: SODIUM HYDROXIDE

Excipient focus: SODIUM PHOSPHATE, DIBASIC

Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Excipient focus: SODIUM STARCH GLYCOLATE TYPE A POTATO

Excipient focus: STARCH, CORN

Excipient focus: SUCROSE

Excipient focus: TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER

FENTANYL drug variants not containing TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER

Company Ingredient NDC
STAT Rx USA LLC fentanyl 42549-573
ProStrakan Inc fentanyl 42747-221
ALVOGEN fentanyl 47781-423
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC fentanyl 49999-833
Janssen Pharmaceuticals Inc fentanyl 50458-101
HJ Harkins Company Inc fentanyl 52959-585
HJ Harkins Company Inc fentanyl 52959-658
>Company >Ingredient >NDC

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Excipient focus: WATER

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Preferred Citation:

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