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Last Updated: December 12, 2025

List of Excipients in API BUPRENORPHINE


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Excipients in NDA-approved (novel) drugs containing BUPRENORPHINE

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
Indivior Inc SUBLOCADE buprenorphine 12496-0100 METHYLPYRROLIDONE
Indivior Inc SUBLOCADE buprenorphine 12496-0100 POLY(DL-LACTIC-CO-GLYCOLIC ACID)
Rhodes Pharmaceuticals LP BUPRENORPHINE buprenorphine 42858-750 ETHYL LEVULINATE
Rhodes Pharmaceuticals LP BUPRENORPHINE buprenorphine 42858-750 OLEYL OLEATE
Rhodes Pharmaceuticals LP BUPRENORPHINE buprenorphine 42858-750 POVIDONE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing BUPRENORPHINE

Company Ingredient NDC Excipient
Teva Pharmaceuticals USA Inc buprenorphine 0093-3656 CITRIC ACID MONOHYDRATE
Teva Pharmaceuticals USA Inc buprenorphine 0093-3656 LEVULINIC ACID
Actavis Pharma Inc buprenorphine 0228-3156 ANHYDROUS CITRIC ACID
Actavis Pharma Inc buprenorphine 0228-3156 CROSPOVIDONE
Actavis Pharma Inc buprenorphine 0228-3156 FD&C YELLOW NO. 6
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for BUPRENORPHINE

Excipient focus: .ALPHA.-TOCOPHEROL

Excipient focus: .ALPHA.-TOCOPHEROL ACETATE

Excipient focus: ACESULFAME POTASSIUM

Excipient focus: ALCOHOL

Excipient focus: ALUMINUM OXIDE

BUPRENORPHINE 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
Bryant Ranch Prepack buprenorphine hydrochloride and naloxone hydrochloride dihydrate 71335-1725
>Company >Ingredient >NDC

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Excipient focus: AMMONIA

Excipient focus: ANHYDROUS CITRIC ACID

Excipient focus: ANHYDROUS DEXTROSE

Excipient focus: ANHYDROUS LACTOSE

BUPRENORPHINE 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
Bryant Ranch Prepack buprenorphine hydrochloride and naloxone hydrochloride dihydrate 71335-1725
>Company >Ingredient >NDC

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Excipient focus: BUTYL ALCOHOL

Excipient focus: BUTYLATED HYDROXYANISOLE

Excipient focus: BUTYLATED HYDROXYTOLUENE

Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CITRIC ACID ACETATE

Excipient focus: CITRIC ACID MONOHYDRATE

Excipient focus: CORN SYRUP

Excipient focus: CROSCARMELLOSE SODIUM

Excipient focus: CROSPOVIDONE

Excipient focus: DEXTROSE

Excipient focus: DIBASIC POTASSIUM PHOSPHATE

Excipient focus: ETHYL LEVULINATE

Excipient focus: FD&C BLUE NO. 1

Excipient focus: FD&C RED NO. 40

Excipient focus: FD&C YELLOW NO. 6

Excipient focus: FERRIC OXIDE YELLOW

Excipient focus: FERROSOFERRIC OXIDE

Excipient focus: GLYCERYL DIOLEATE

Excipient focus: HYDROCHLORIC ACID

Excipient focus: HYDROXYETHYL CELLULOSE

Excipient focus: HYDROXYPROPYL CELLULOSE

Excipient focus: HYPROMELLOSE 2910

Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LACTOSE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: LECITHIN, SOYBEAN

Excipient focus: LEVULINIC ACID

Excipient focus: MAGNESIUM STEARATE

Excipient focus: MALTITOL

BUPRENORPHINE drug variants containing MALTITOL

Company Ingredient NDC
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8765
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8767
Indivior Inc buprenorphine hydrochloride, naloxone hydrochloride 0781-7216
INDIVIOR INC buprenorphine hydrochloride, naloxone hydrochloride 12496-1202
Aveva Drug Delivery Systems Inc buprenorphine and naloxone 3215-6521
>Company >Ingredient >NDC

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Excipient focus: MALTODEXTRIN

Excipient focus: MANNITOL

Excipient focus: MENTHOL

Excipient focus: METHYLPARABEN

Excipient focus: METHYLPYRROLIDONE

Excipient focus: OLEYL OLEATE

Excipient focus: PEPPERMINT OIL

Excipient focus: POLY(DL-LACTIC-CO-GLYCOLIC ACID)

Excipient focus: POLYCARBOPHIL

Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYETHYLENE GLYCOL 8000

Excipient focus: POLYETHYLENE GLYCOLS

Excipient focus: POLYETHYLENE OXIDE 100000

Excipient focus: POLYETHYLENE OXIDE 1000000

Excipient focus: POLYETHYLENE OXIDE 200000

Excipient focus: POLYETHYLENE OXIDE 2000000

Excipient focus: POLYETHYLENE OXIDE 900000

Excipient focus: POTASSIUM HYDROXIDE

Excipient focus: POVIDONE

Excipient focus: POVIDONE K29/32

Excipient focus: POVIDONE K30

Excipient focus: POVIDONE K90

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN

Excipient focus: SACCHARIN SODIUM

Excipient focus: SHELLAC

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM BENZOATE

Excipient focus: SODIUM CITRATE

Excipient focus: SODIUM HYDROXIDE

Excipient focus: SODIUM METABISULFITE

Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

Excipient focus: SODIUM STEARYL FUMARATE

BUPRENORPHINE drug variants containing SODIUM STEARYL FUMARATE

Company Ingredient NDC
PAI Holdings LLC dba Pharmaceutical Associates Inc and dba PAI Pharma buprenorphine hydrochloride 0121-1019
A-S Medication Solutions buprenorphine hydrochloride 50090-1571
A-S Medication Solutions buprenorphine hydrochloride 50090-7559
Akorn Operating Company LLC (dba Akorn) buprenorphine hydrochloride 50383-924
Aidarex Pharmaceuticals LLC buprenorphine hydrochloride 53217-246
>Company >Ingredient >NDC

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Excipient focus: STARCH, CORN

Excipient focus: SUCRALOSE

BUPRENORPHINE drug variants containing SUCRALOSE

Company Ingredient NDC
Actavis Pharma Inc buprenorphine and naloxone 0228-3154
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

Excipient focus: ZEA MAYS

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Preferred Citation:

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