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Last Updated: November 22, 2024

List of Excipients in API buprenorphine hydrochloride


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Excipients in NDA-approved (novel) drugs containing buprenorphine hydrochloride

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
Indivior Inc BUPRENEX buprenorphine hydrochloride 12496-0757 ANHYDROUS DEXTROSE
Indivior Inc BUPRENEX buprenorphine hydrochloride 12496-0757 HYDROCHLORIC ACID
Indivior Inc BUPRENEX buprenorphine hydrochloride 12496-0757 WATER
Quality Care Products LLC BELBUCA buprenorphine hydrochloride 55700-867 .ALPHA.-TOCOPHEROL ACETATE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing buprenorphine hydrochloride

Company Ingredient NDC Excipient
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride 0121-1019 ANHYDROUS CITRIC ACID
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride 0121-1019 LACTOSE MONOHYDRATE
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride 0121-1019 MANNITOL
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride 0121-1019 POVIDONE K30
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for buprenorphine hydrochloride

Excipient focus: .ALPHA.-TOCOPHEROL ACETATE

Excipient focus: ACESULFAME POTASSIUM

buprenorphine hydrochloride drug variants containing ACESULFAME POTASSIUM

Company Ingredient NDC
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride and naloxone hydrochloride 0121-1018
Akorn Operating Company LLC (dba Akorn) buprenorphine hydrochloride and naloxone hydrochloride 50383-294
Aidarex Pharmaceuticals LLC buprenorphine hydrochloride and naloxone hydrochloride 53217-138
Golden State Medical Supply Inc buprenorphine hydrochloride and naloxone hydrochloride 60429-586
>Company >Ingredient >NDC

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Excipient focus: ALUMINUM OXIDE

buprenorphine hydrochloride drug variants containing ALUMINUM OXIDE

Company Ingredient NDC
SpecGx LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0406-8005
Correct Rx Pharmacy Services Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 24555-8005
Quality Care Products LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 55700-901
Clinical Solutions Wholesale LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 58118-8005
>Company >Ingredient >NDC

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Excipient focus: ANHYDROUS CITRIC ACID

Excipient focus: ANHYDROUS DEXTROSE

Excipient focus: ANHYDROUS LACTOSE

buprenorphine hydrochloride drug variants containing ANHYDROUS LACTOSE

Company Ingredient NDC
SpecGx LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0406-8005
Correct Rx Pharmacy Services Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 24555-8005
Quality Care Products LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 55700-901
Clinical Solutions Wholesale LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 58118-8005
>Company >Ingredient >NDC

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Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CITRIC ACID MONOHYDRATE

Excipient focus: CROSCARMELLOSE SODIUM

Excipient focus: CROSPOVIDONE

buprenorphine hydrochloride drug variants containing CROSPOVIDONE

Company Ingredient NDC
Accord Healthcare Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 16729-549
REMEDYREPACK INC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 70518-4001
REMEDYREPACK INC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 70518-4002
Bryant Ranch Prepack buprenorphine hydrochloride and naloxone hydrochloride dihydrate 71335-1858
>Company >Ingredient >NDC

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Excipient focus: DEXTROSE

Excipient focus: FD&C YELLOW NO. 6

buprenorphine hydrochloride drug variants containing FD&C YELLOW NO. 6

Company Ingredient NDC
Physicians Total Care Inc buprenorphine hydrochloride and naloxone hydrochloride 54868-5750
Hikma Pharmaceuticals USA Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0054-0188
SpecGx LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0406-8005
Major Pharmaceuticals buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0904-7009
>Company >Ingredient >NDC

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Excipient focus: FERRIC OXIDE YELLOW

Excipient focus: HYDROCHLORIC ACID

Excipient focus: HYDROXYETHYL CELLULOSE

Excipient focus: HYDROXYPROPYL CELLULOSE

Excipient focus: HYPROMELLOSES

Excipient focus: LACTOSE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: MAGNESIUM STEARATE

Excipient focus: MALTITOL

Excipient focus: MANNITOL

Excipient focus: MENTHOL

Excipient focus: METHYLPARABEN

Excipient focus: PEPPERMINT OIL

Excipient focus: POLYCARBOPHIL

Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYETHYLENE GLYCOLS

Excipient focus: POVIDONE

buprenorphine hydrochloride drug variants containing POVIDONE

Company Ingredient NDC
Hikma Pharmaceuticals USA Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0054-0188
SpecGx LLC buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0406-8005
Major Pharmaceuticals buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0904-7009
Accord Healthcare Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 16729-549
>Company >Ingredient >NDC

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Excipient focus: POVIDONE K30

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN

Excipient focus: SACCHARIN SODIUM

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM BENZOATE

Excipient focus: SODIUM CITRATE

buprenorphine hydrochloride drug variants containing SODIUM CITRATE

Company Ingredient NDC
bryant ranch prepack buprenorphine hydrochloride 63629-4092
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride and naloxone hydrochloride 0121-1018
Akorn Operating Company LLC (dba Akorn) buprenorphine hydrochloride and naloxone hydrochloride 50383-294
Aidarex Pharmaceuticals LLC buprenorphine hydrochloride and naloxone hydrochloride 53217-138
>Company >Ingredient >NDC

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Excipient focus: SODIUM HYDROXIDE

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

Excipient focus: SODIUM STEARYL FUMARATE

Excipient focus: STARCH, CORN

Excipient focus: SUCRALOSE

buprenorphine hydrochloride drug variants containing SUCRALOSE

Company Ingredient NDC
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-907
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-914
Hikma Pharmaceuticals USA Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0054-0188
Major Pharmaceuticals buprenorphine hydrochloride and naloxone hydrochloride dihydrate 0904-7009
>Company >Ingredient >NDC

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Excipient focus: TITANIUM DIOXIDE

Excipient focus: TRISODIUM CITRATE DIHYDRATE

Excipient focus: WATER

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Preferred Citation:

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