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Last Updated: November 4, 2024

List of Excipients in API amphetamine


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Excipients in NDA-approved (novel) drugs containing amphetamine

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 ANHYDROUS CITRIC ACID 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 GLYCERIN 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 METHYLPARABEN 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 MODIFIED CORN STARCH 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 POLYSORBATE 80 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 POLYVINYL ACETATE 2027-03-15
NextWave Pharmaceuticals Inc DYANAVEL XR amphetamine 24478-102 POVIDONE 2027-03-15
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing amphetamine

Company Ingredient NDC Excipient
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563 CELLULOSE, MICROCRYSTALLINE
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563 CROSPOVIDONE
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563 SILICON DIOXIDE
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563 STEARIC ACID
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563 TALC
Bionpharma Inc amphetamine 69452-227 CELLULOSE, MICROCRYSTALLINE
Bionpharma Inc amphetamine 69452-227 CROSPOVIDONE
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for amphetamine

Excipient focus: ANHYDROUS CITRIC ACID

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CITRIC ACID MONOHYDRATE

Excipient focus: CORN OIL

Excipient focus: CROSPOVIDONE

Excipient focus: DIBUTYL SEBACATE

Excipient focus: DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

amphetamine drug variants not containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

Company Ingredient NDC
NextWave Pharmaceuticals Inc amphetamine 24478-102
Tris Pharma Inc amphetamine 27808-102
Prasco Laboratories amphetamine 66993-360
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563
Bionpharma Inc amphetamine 69452-227
Neos Therapeutics LP amphetamine 70165-003
Neos Therapeutics LP amphetamine 70165-005
>Company >Ingredient >NDC

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Excipient focus: ETHYLCELLULOSE

Excipient focus: FD&C BLUE NO. 1

Excipient focus: FD&C BLUE NO. 1 ALUMINUM LAKE

Excipient focus: FRUCTOSE

Excipient focus: GLYCERIN

Excipient focus: MAGNESIUM STEARATE

amphetamine drug variants containing MAGNESIUM STEARATE

Company Ingredient NDC
Neos Therapeutics LP amphetamine 70165-005
Neos Therapeutics Brands LLC amphetamine 70165-030
Azurity Pharmaceuticals Inc amphetamine sulfate 24338-031
Solco Healthcare US LLC amphetamine sulfate 43547-457
Ingenus Pharmaceuticals LLC amphetamine sulfate 50742-651
Bryant Ranch Prepack amphetamine sulfate 63629-1115
Ascend Laboratories LLC amphetamine sulfate 67877-710
>Company >Ingredient >NDC

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Excipient focus: MALIC ACID

Excipient focus: MANNITOL

Excipient focus: METHACRYLIC ACID

Excipient focus: METHYLPARABEN

Excipient focus: MODIFIED CORN STARCH

Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYSORBATE 80

Excipient focus: POLYVINYL ACETATE

Excipient focus: POVIDONE

Excipient focus: POVIDONE K30

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM LAURYL SULFATE

Excipient focus: SODIUM POLYSTYRENE SULFONATE

amphetamine drug variants not containing SODIUM POLYSTYRENE SULFONATE

Company Ingredient NDC
Amneal Pharmaceuticals NY LLC amphetamine 69238-1563
Bionpharma Inc amphetamine 69452-227
SpecGx LLC amphetamine sulfate 0406-1219
Lannett Company Inc amphetamine sulfate 0527-2524
Aurolife Pharma LLC amphetamine sulfate 13107-259
AZURITY PHARMACEUTICALS INC amphetamine sulfate 24338-022
Azurity Pharmaceuticals Inc amphetamine sulfate 24338-031
>Company >Ingredient >NDC

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Excipient focus: SORBITOL

Excipient focus: STEARIC ACID

Excipient focus: SUCRALOSE

Excipient focus: TALC

Excipient focus: TRIACETIN

Excipient focus: TRIETHYL CITRATE

Excipient focus: WATER

Excipient focus: XANTHAN GUM

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Preferred Citation:

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