Sonata

Product NDC: 60793-146
11-digit product format: 607930146
Labeler code: 60793
Product ID: 60793-146_e1f1fb8b-9f7b-4f27-a830-aa049ad07538
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zaleplon
Dosage form: CAPSULE
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA020859
Marketing category: NDA
Marketing start: 1999-08-13
Marketing end: 0000-00-00
Substance: ZALEPLON
Active strength: 10 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: No
Listing certified through: 2020-12-31
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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60793-146-01	EA - Each	60793-146	7bbfaffd-d364-45ee-9b3d-206e540596ee	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
ZALEPLON	ACTIVE MOIETY	S62U433RMH	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SONATA (ZALEPLON) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	2

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
261286	Sonata 10 MG Oral Capsule	PSN	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
261285	Sonata 5 MG Oral Capsule	PSN	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
313761	zaleplon 10 MG Oral Capsule	PSN	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
313762	zaleplon 5 MG Oral Capsule	PSN	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
261286	zaleplon 10 MG Oral Capsule [Sonata]	SBD	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
261285	zaleplon 5 MG Oral Capsule [Sonata]	SBD	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
313761	zaleplon 10 MG Oral Capsule	SCD	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
313762	zaleplon 5 MG Oral Capsule	SCD	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
261286	Sonata 10 MG Oral Capsule	SY	43ac81cb-1e3f-4d44-86bd-13db2721d060	2
261285	Sonata 5 MG Oral Capsule	SY	43ac81cb-1e3f-4d44-86bd-13db2721d060	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sonata - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-05-27	HUMAN PRESCRIPTION DRUG LABEL	2