List of Excipients in API zaleplon

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Excipients in NDA-approved (novel) drugs containing zaleplon

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Rebel Distributors Corp	ZALEPLON	zaleplon	21695-376	CELLULOSE, MICROCRYSTALLINE
Rebel Distributors Corp	ZALEPLON	zaleplon	21695-376	D&C YELLOW NO. 10
Rebel Distributors Corp	ZALEPLON	zaleplon	21695-376	FD&C BLUE NO. 1
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing zaleplon

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084	ANHYDROUS LACTOSE
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084	CELLULOSE, MICROCRYSTALLINE
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084	D&C YELLOW NO. 10
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for zaleplon

Excipient focus: ALUMINUM OXIDE

zaleplon drug variants containing ALUMINUM OXIDE

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Company	Ingredient	NDC
Dispensing Solutions Inc	zaleplon	66336-056
>Company	>Ingredient	>NDC

zaleplon drug variants not containing ALUMINUM OXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS LACTOSE

zaleplon drug variants containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
PD-Rx Pharmaceuticals Inc	zaleplon	43063-912
>Company	>Ingredient	>NDC

zaleplon drug variants not containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

zaleplon drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: COLLOIDAL SILICON DIOXIDE

zaleplon drug variants containing COLLOIDAL SILICON DIOXIDE

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Company	Ingredient	NDC
DIRECT RX	zaleplon	61919-629
>Company	>Ingredient	>NDC

zaleplon drug variants not containing COLLOIDAL SILICON DIOXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: D&C YELLOW NO. 10

zaleplon drug variants containing D&C YELLOW NO. 10

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
PD-Rx Pharmaceuticals Inc	zaleplon	43063-912
>Company	>Ingredient	>NDC

zaleplon drug variants not containing D&C YELLOW NO. 10

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Company	Ingredient	NDC
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
OrchidPharma Inc	zaleplon	42043-210
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 1

zaleplon drug variants containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C BLUE NO. 1

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2

zaleplon drug variants containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Dispensing Solutions Inc	zaleplon	66336-056
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C BLUE NO. 2

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: FD&C GREEN NO. 3

zaleplon drug variants containing FD&C GREEN NO. 3

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Company	Ingredient	NDC
Rebel Distributors Corp	zaleplon	21695-376
PD-Rx Pharmaceuticals Inc	zaleplon	43063-505
Physicians Total Care Inc	zaleplon	54868-5139
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C GREEN NO. 3

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
>Company	>Ingredient	>NDC

Excipient focus: FD&C RED NO. 40

zaleplon drug variants containing FD&C RED NO. 40

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Company	Ingredient	NDC
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
OrchidPharma Inc	zaleplon	42043-210
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C RED NO. 40

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
PD-Rx Pharmaceuticals Inc	zaleplon	43063-505
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 5

zaleplon drug variants containing FD&C YELLOW NO. 5

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Company	Ingredient	NDC
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C YELLOW NO. 5

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	42254-130
Rebel Distributors Corp	zaleplon	42254-147
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 6

zaleplon drug variants containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
PD-Rx Pharmaceuticals Inc	zaleplon	43063-912
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FD&C YELLOW NO. 6

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE BLACK

zaleplon drug variants containing FERRIC OXIDE BLACK

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Company	Ingredient	NDC
HJ Harkins Company Inc	zaleplon	52959-957
Ascend Laboratories LLC	zaleplon	67877-210
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FERRIC OXIDE BLACK

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

zaleplon drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
Rebel Distributors Corp	zaleplon	42254-130
>Company	>Ingredient	>NDC

zaleplon drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
OrchidPharma Inc	zaleplon	42043-210
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

zaleplon drug variants containing GELATIN

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing GELATIN

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE

zaleplon drug variants containing LACTOSE

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Company	Ingredient	NDC
Rebel Distributors Corp	zaleplon	21695-376
HJ Harkins Company Inc	zaleplon	52959-957
Ascend Laboratories LLC	zaleplon	67877-210
>Company	>Ingredient	>NDC

zaleplon drug variants not containing LACTOSE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE MONOHYDRATE

zaleplon drug variants containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
Aidarex Pharmaceuticals LLC	zaleplon	33261-486
OrchidPharma Inc	zaleplon	42043-210
>Company	>Ingredient	>NDC

zaleplon drug variants not containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
PD-Rx Pharmaceuticals Inc	zaleplon	43063-912
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

zaleplon drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
PD-Rx Pharmaceuticals Inc	zaleplon	43063-505
Physicians Total Care Inc	zaleplon	54868-5909
Rising Health LLC	zaleplon	57237-239
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

zaleplon drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Dispensing Solutions Inc	zaleplon	66336-056
>Company	>Ingredient	>NDC

zaleplon drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

zaleplon drug variants containing SHELLAC

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Company	Ingredient	NDC
PD-Rx Pharmaceuticals Inc	zaleplon	43063-505
Physicians Total Care Inc	zaleplon	54868-5909
Rising Health LLC	zaleplon	57237-239
>Company	>Ingredient	>NDC

zaleplon drug variants not containing SHELLAC

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

zaleplon drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
HJ Harkins Company Inc	zaleplon	52959-957
DIRECT RX	zaleplon	61919-629
Ascend Laboratories LLC	zaleplon	67877-210
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE, COLLOIDAL

zaleplon drug variants containing SILICON DIOXIDE, COLLOIDAL

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Company	Ingredient	NDC
HJ Harkins Company Inc	zaleplon	52959-957
Ascend Laboratories LLC	zaleplon	67877-210
>Company	>Ingredient	>NDC

zaleplon drug variants not containing SILICON DIOXIDE, COLLOIDAL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: SODIUM LAURYL SULFATE

zaleplon drug variants containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
OrchidPharma Inc	zaleplon	42043-210
Preferred Pharmaceuticals Inc	zaleplon	68788-8725
Bionpharma Inc	zaleplon	69452-364
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

zaleplon drug variants containing STARCH, CORN

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

zaleplon drug variants containing STEARIC ACID

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Company	Ingredient	NDC
PD-Rx Pharmaceuticals Inc	zaleplon	43063-505
Physicians Total Care Inc	zaleplon	54868-5909
Rising Health LLC	zaleplon	57237-239
>Company	>Ingredient	>NDC

zaleplon drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

zaleplon drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	zaleplon	0054-0084
Rebel Distributors Corp	zaleplon	21695-376
Unichem Pharmaceuticals (USA) Inc	zaleplon	29300-131
>Company	>Ingredient	>NDC

zaleplon drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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