ZALEPLON

Product NDC: 65862-214
11-digit product format: 658620214
Labeler code: 65862
Product ID: 65862-214_36ab371f-c2fe-4c1d-ad60-801b8f118f4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZALEPLON
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
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#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZALEPLON	5 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	Strength	SPL version
65862-214-01	ZALEPLON	100 in 1 BOTTLE	CAPSULE	100		11
65862-214-05	ZALEPLON	500 in 1 BOTTLE	CAPSULE	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-214-01	EA - Each	65862-214	78904159-05d8-491e-99e2-047c47914f5a	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-214	ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED]	11	Current NDC, Legacy NDC, 2 package rows	20240510_e092f3ca-bf44-4568-a72c-3fb2cf5b192b.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
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
313761	zaleplon 10 MG Oral Capsule	PSN	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	11
313762	zaleplon 5 MG Oral Capsule	PSN	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	11
313761	zaleplon 10 MG Oral Capsule	SCD	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	11
313762	zaleplon 5 MG Oral Capsule	SCD	e092f3ca-bf44-4568-a72c-3fb2cf5b192b	11
313761	zaleplon 10 MG Oral Capsule	PSN	8fef39a1-b4bf-4583-b6f2-5b89990c6c86	1
313762	zaleplon 5 MG Oral Capsule	PSN	8fef39a1-b4bf-4583-b6f2-5b89990c6c86	1
313761	zaleplon 10 MG Oral Capsule	SCD	8fef39a1-b4bf-4583-b6f2-5b89990c6c86	1
313762	zaleplon 5 MG Oral Capsule	SCD	8fef39a1-b4bf-4583-b6f2-5b89990c6c86	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-214-01	65862021401	100 CAPSULE in 1 BOTTLE (65862-214-01)	100 capsule	2008-06-06	0000-00-00	No	No	Current
65862-214-05	65862021405	500 CAPSULE in 1 BOTTLE (65862-214-05)	500 capsule	2008-06-06	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
Zaleplon Capsules USP CIV Rx only	Aurobindo Pharma Limited	2024-05-08	Human Prescription Drug Label	11
Zaleplon Capsules CIV	Physicians Total Care, Inc.	2012-05-23	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#