zaleplon

Product NDC: 29300-132
11-digit product format: 293000132
Labeler code: 29300
Product ID: 29300-132_24b4fbb6-3d16-48f7-864c-71e85813a9a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zaleplon
Dosage form: CAPSULE
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA078989
Marketing category: ANDA
Marketing start: 2009-05-05
Substance: ZALEPLON
Active strength: 10 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#

Finished product: Yes
Brand name base: zaleplon
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZALEPLON	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	S62U433RMH
Rxcui	313761, 313762

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-132-01	zaleplon	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	10
29300-132-05	zaleplon	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	10
29300-132-10	zaleplon	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-132-01	EA - Each	29300-132	ed9414a8-a518-4539-bb1d-166854dd95fc	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	5
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [DIRECT RX]	2
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [DIRECT RX]	2
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [DIRECT RX]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [DIRECT RX]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [DIRECT RX]	2
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-132	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	10	Current NDC, Legacy NDC, 3 package rows	20210626_57a1a11d-7767-4caf-b98a-75d7561d9165.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313761	zaleplon 10 MG Oral Capsule	PSN	2cc7adee-2c4c-4fed-9914-545e70dba773	17
313761	zaleplon 10 MG Oral Capsule	SCD	2cc7adee-2c4c-4fed-9914-545e70dba773	17
313761	zaleplon 10 MG Oral Capsule	PSN	8276a418-6a4c-4b81-8170-2d3838576c6d	11
313761	zaleplon 10 MG Oral Capsule	SCD	8276a418-6a4c-4b81-8170-2d3838576c6d	11
313761	zaleplon 10 MG Oral Capsule	PSN	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313762	zaleplon 5 MG Oral Capsule	PSN	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313761	zaleplon 10 MG Oral Capsule	SCD	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313762	zaleplon 5 MG Oral Capsule	SCD	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313761	zaleplon 10 MG Oral Capsule	PSN	b8032b14-5068-19d5-e063-839ed25d7200	8
313761	zaleplon 10 MG Oral Capsule	PSN	b0476859-07af-47f1-aec7-61aea0d99d24	8
313761	zaleplon 10 MG Oral Capsule	SCD	b8032b14-5068-19d5-e063-839ed25d7200	8
313761	zaleplon 10 MG Oral Capsule	SCD	b0476859-07af-47f1-aec7-61aea0d99d24	8
313761	zaleplon 10 MG Oral Capsule	PSN	7d638bba-3180-4fb5-e053-2991aa0a3f34	2
313761	zaleplon 10 MG Oral Capsule	PSN	d4871d67-cdf5-4801-9349-9ec4146df49f	2
313761	zaleplon 10 MG Oral Capsule	SCD	7d638bba-3180-4fb5-e053-2991aa0a3f34	2
313761	zaleplon 10 MG Oral Capsule	SCD	d4871d67-cdf5-4801-9349-9ec4146df49f	2
313761	zaleplon 10 MG Oral Capsule	PSN	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313761	zaleplon 10 MG Oral Capsule	PSN	b9c6ed9c-c081-4a05-8f5e-bf646cfd5396	1
313762	zaleplon 5 MG Oral Capsule	PSN	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313761	zaleplon 10 MG Oral Capsule	SCD	b9c6ed9c-c081-4a05-8f5e-bf646cfd5396	1
313761	zaleplon 10 MG Oral Capsule	SCD	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313762	zaleplon 5 MG Oral Capsule	SCD	423a4d98-f648-4eed-bd20-857c5a8dde5b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-132-01	29300013201	100 CAPSULE in 1 BOTTLE, PLASTIC (29300-132-01)	100 capsule	2009-05-05	0000-00-00	No	No	Current
29300-132-05	29300013205	500 CAPSULE in 1 BOTTLE, PLASTIC (29300-132-05)	500 capsule	2009-05-05	0000-00-00	No	No	Current
29300-132-10	29300013210	1000 CAPSULE in 1 BOTTLE, PLASTIC (29300-132-10)	1000 capsule	2009-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zaleplon Capsules USP	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	17
Zaleplon Capsules USP	Preferred Pharmaceuticals Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	8
Zaleplon Capsules USP	A-S Medication Solutions	2024-01-07	HUMAN PRESCRIPTION DRUG LABEL	11
Zaleplon Capsules USP	Bryant Ranch Prepack	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	8
Zaleplon Capsules USP	Unichem Pharmaceuticals (USA), Inc.	2021-06-28	HUMAN PRESCRIPTION DRUG LABEL	10
Zaleplon Capsules USP	medsource pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
ZALEPLON	DIRECT RX	2015-08-13	HUMAN PRESCRIPTION DRUG LABEL	2
Zaleplon Capsules	Aidarex Pharmaceuticals LLC	2014-01-31	HUMAN PRESCRIPTION DRUG LABEL	1
Zaleplon Capsules	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1

zaleplon

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#