ZALEPLON

Product NDC: 43063-505
11-digit product format: 430630505
Labeler code: 43063
Product ID: 43063-505_41389c99-6a99-0d1f-e063-6394a90aed19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZALEPLON
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA078829
Marketing category: ANDA
Marketing start: 2008-06-06
Substance: ZALEPLON
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ZALEPLON	5 mg/1

Field, Values table
Field	Values
Unii	S62U433RMH
Rxcui	313762

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
11ca9bc5-afb0-a2d5-938a-c2d33f89f4ab	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43063-505-30	ZALEPLON	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		15

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-505-30	EA - Each	43063-505	d105efb4-af08-4067-9b03-30eb391f236e	1	2014-05-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-505	ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 1 package rows	20240809_9c83b71e-8344-4c77-b7f6-a9c862f9e7dd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S62U433RMH	ZALEPLON	151319-34-5	ZALEPLON

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313762	zaleplon 5 MG Oral Capsule	PSN	9c83b71e-8344-4c77-b7f6-a9c862f9e7dd	15
313762	zaleplon 5 MG Oral Capsule	SCD	9c83b71e-8344-4c77-b7f6-a9c862f9e7dd	15

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-505-30	43063050530	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30)	30 capsule	2013-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zaleplon Capsules USP CIV Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	15