ZALEPLON

Product NDC: 21695-376
11-digit product format: 216950376
Labeler code: 21695
Product ID: 21695-376_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ZALEPLON
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA020859
Marketing category: NDA
Marketing start: 2008-05-01
Marketing end: 0000-00-00
Substance: ZALEPLON
Active strength: 5 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-376-60	2019-09-24	C162847	48780-1	934fe258-4b0f-48b1-e053-8cdaa90a720a	Zaleplon Capsules 5 mg and 10 mg CIV Rx only

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-376-60	EA - Each	21695-376	69dcea18-ffc1-4f99-8eaf-7aaedf7adcba	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [REBEL DISTRIBUTORS CORP.]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zaleplon Capsules 5 mg and 10 mg CIV Rx only	Rebel Distributors Corp.	2009-10-10	HUMAN PRESCRIPTION DRUG LABEL	1