List of Excipients in API paliperidone palmitate

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Excipients in NDA-approved (novel) drugs containing paliperidone palmitate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Janssen Pharmaceuticals Inc	INVEGA SUSTENNA	paliperidone palmitate	50458-560	CITRIC ACID MONOHYDRATE
Janssen Pharmaceuticals Inc	INVEGA SUSTENNA	paliperidone palmitate	50458-560	POLYETHYLENE GLYCOL 4000
Janssen Pharmaceuticals Inc	INVEGA SUSTENNA	paliperidone palmitate	50458-560	POLYSORBATE 20
Janssen Pharmaceuticals Inc	INVEGA SUSTENNA	paliperidone palmitate	50458-560	SODIUM HYDROXIDE
Janssen Pharmaceuticals Inc	INVEGA SUSTENNA	paliperidone palmitate	50458-560	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Detailed excipient profiles for paliperidone palmitate

Excipient focus: CITRIC ACID MONOHYDRATE

paliperidone palmitate drug variants containing CITRIC ACID MONOHYDRATE

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing CITRIC ACID MONOHYDRATE

Glossary

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 4000

paliperidone palmitate drug variants containing POLYETHYLENE GLYCOL 4000

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing POLYETHYLENE GLYCOL 4000

Glossary

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 20

paliperidone palmitate drug variants containing POLYSORBATE 20

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing POLYSORBATE 20

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

paliperidone palmitate drug variants containing SODIUM HYDROXIDE

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing SODIUM HYDROXIDE

Glossary

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

paliperidone palmitate drug variants containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC

paliperidone palmitate drug variants containing SODIUM PHOSPHATE, MONOBASIC

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing SODIUM PHOSPHATE, MONOBASIC

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

paliperidone palmitate drug variants containing SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
>Company	>Ingredient	>NDC

Excipient focus: WATER

paliperidone palmitate drug variants containing WATER

Glossary

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Company	Ingredient	NDC
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-560
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-606
Janssen Pharmaceuticals Inc	paliperidone palmitate	50458-611
Shandong Luye Pharmaceutical Co Ltd	paliperidone palmitate	72526-105
>Company	>Ingredient	>NDC

paliperidone palmitate drug variants not containing WATER

Glossary

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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