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Last Updated: November 21, 2024

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
Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE buprenorphine 55700-579 ETHYL LEVULINATE
>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
Actavis Pharma Inc buprenorphine 0228-3156 LACTOSE MONOHYDRATE
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for buprenorphine

Excipient focus: .ALPHA.-TOCOPHEROL

buprenorphine drug variants containing .ALPHA.-TOCOPHEROL

Company Ingredient NDC
Rhodes Pharmaceuticals LP buprenorphine and naloxone 42858-601
American Health Packaging buprenorphine and naloxone 60687-626
Bryant Ranch Prepack buprenorphine and naloxone 63629-9482
Bryant Ranch Prepack buprenorphine and naloxone 63629-9483
REMEDYREPACK INC buprenorphine and naloxone 70518-3389
REMEDYREPACK INC buprenorphine and naloxone 70518-3487
>Company >Ingredient >NDC

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Excipient focus: .ALPHA.-TOCOPHEROL ACETATE

Excipient focus: ACESULFAME POTASSIUM

buprenorphine drug variants containing ACESULFAME POTASSIUM

Company Ingredient NDC
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8765
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8767
SpecGx LLC buprenorphine and naloxone 0406-1923
Correct Rx Pharmacy Services Inc buprenorphine and naloxone 24555-0970
Rhodes Pharmaceuticals LP buprenorphine and naloxone 42858-601
DrReddys Laboratories Inc buprenorphine and naloxone 43598-579
>Company >Ingredient >NDC

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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
Contract Pharmacy Services-PA buprenorphine hydrochloride sublingual 67046-996
>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

buprenorphine drug variants containing CITRIC ACID MONOHYDRATE

Company Ingredient NDC
Teva Pharmaceuticals USA Inc buprenorphine 0093-3656
Alvogen Inc buprenorphine and naloxone 47781-355
Almatica Pharma Inc buprenorphine and naloxone 52427-692
Bryant Ranch Prepack buprenorphine and naloxone 63629-4028
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-907
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-914
>Company >Ingredient >NDC

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Excipient focus: CORN SYRUP

buprenorphine drug variants containing CORN SYRUP

Company Ingredient NDC
Rhodes Pharmaceuticals LP buprenorphine and naloxone 42858-601
American Health Packaging buprenorphine and naloxone 60687-626
Bryant Ranch Prepack buprenorphine and naloxone 63629-9482
Bryant Ranch Prepack buprenorphine and naloxone 63629-9483
REMEDYREPACK INC buprenorphine and naloxone 70518-3389
REMEDYREPACK INC buprenorphine and naloxone 70518-3487
>Company >Ingredient >NDC

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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

buprenorphine drug variants containing HYDROCHLORIC ACID

Company Ingredient NDC
Hikma Pharmaceuticals USA Inc buprenorphine hydrochloride 0143-9246
Hospira Inc buprenorphine hydrochloride 0409-2012
American Regent Inc buprenorphine hydrochloride 0517-0725
Indivior Inc buprenorphine hydrochloride 12496-0757
Rebel Distributors Corp buprenorphine hydrochloride 21695-515
Par Pharmaceutical Inc buprenorphine hydrochloride 42023-179
>Company >Ingredient >NDC

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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
DrReddys Laboratories Inc buprenorphine and naloxone 43598-579
DrReddys Laboratories Inc buprenorphine and naloxone 43598-580
>Company >Ingredient >NDC

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Excipient focus: MALTODEXTRIN

buprenorphine drug variants containing MALTODEXTRIN

Company Ingredient NDC
Rhodes Pharmaceuticals LP buprenorphine and naloxone 42858-601
American Health Packaging buprenorphine and naloxone 60687-626
Bryant Ranch Prepack buprenorphine and naloxone 63629-9482
Bryant Ranch Prepack buprenorphine and naloxone 63629-9483
REMEDYREPACK INC buprenorphine and naloxone 70518-3389
REMEDYREPACK INC buprenorphine and naloxone 70518-3487
>Company >Ingredient >NDC

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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

buprenorphine drug variants containing POLYETHYLENE OXIDE 900000

Company Ingredient NDC
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8765
Mylan Pharmaceuticals Inc buprenorphine and naloxone 0378-8767
Alvogen Inc buprenorphine and naloxone 47781-355
INGENUS PHARMACEUTICALS LLC buprenorphine and naloxone 50742-364
Almatica Pharma Inc buprenorphine and naloxone 52427-692
Apotex Corp buprenorphine and naloxone 60505-7053
>Company >Ingredient >NDC

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Excipient focus: POTASSIUM HYDROXIDE

Excipient focus: POVIDONE

Excipient focus: POVIDONE K29/32

Excipient focus: POVIDONE K30

Excipient focus: POVIDONE K90

Excipient focus: PROPYLENE GLYCOL

buprenorphine drug variants containing PROPYLENE GLYCOL

Company Ingredient NDC
Alvogen Inc buprenorphine and naloxone 47781-355
Almatica Pharma Inc buprenorphine and naloxone 52427-692
BioDelivery Sciences International Inc buprenorphine and naloxone 59385-012
Alvogen Inc buprenorphine buccal 47781-471
Quality Care Products LLC buprenorphine hydrochloride 55700-867
BioDelivery Sciences International Inc buprenorphine hydrochloride 59385-021
>Company >Ingredient >NDC

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Excipient focus: PROPYLPARABEN

Excipient focus: SACCHARIN SODIUM

Excipient focus: SHELLAC

Excipient focus: SILICON DIOXIDE

buprenorphine drug variants containing SILICON DIOXIDE

Company Ingredient NDC
Lannett Company Inc buprenorphine and naloxone 62175-452
REMEDYREPACK INC buprenorphine and naloxone 70518-2311
Bryant Ranch Prepack buprenorphine and naloxone 71335-1296
Bryant Ranch Prepack buprenorphine and naloxone 71335-1378
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-907
Orexo US Inc buprenorphine hydrochloride and naloxone hydrochloride 54123-914
>Company >Ingredient >NDC

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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
Akorn Operating Company LLC (dba Akorn) buprenorphine hydrochloride 50383-924
Aidarex Pharmaceuticals LLC buprenorphine hydrochloride 53217-246
Bryant Ranch Prepack buprenorphine hydrochloride 63629-7125
TYA Pharmaceuticals buprenorphine hydrochloride 64725-0930
>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
Accord Healthcare Inc buprenorphine hydrochloride and naloxone hydrochloride dihydrate 16729-549
>Company >Ingredient >NDC

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Excipient focus: TITANIUM DIOXIDE

Excipient focus: TRISODIUM CITRATE DIHYDRATE

Excipient focus: WATER

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