ESZOPICLONE

Product NDC: 47335-586
11-digit product format: 473350586
Labeler code: 47335
Product ID: 47335-586_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA091103
Marketing category: ANDA
Marketing start: 2014-04-15
Substance: ESZOPICLONE
Active strength: 1 mg/1
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: ESZOPICLONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESZOPICLONE	1 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	UZX80K71OE
Rxcui	485440, 485442, 485465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f65008ed-f925-2246-581a-e6a3201df7e4	Product name	5	20250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47335-586-08	ESZOPICLONE	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
47335-586-18	ESZOPICLONE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
47335-586-83	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
47335-586-88	ESZOPICLONE	100 in 1 BOTTLE	TABLET, FILM COATED	100	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-586-83	EA - Each	47335-586	9fc4806d-a369-49de-bdc3-f6fbb0d2e706	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]	5
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-586	ESZOPICLONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20181025_8bb1965e-7845-4c5b-b021-38e251303d68.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UZX80K71OE	ESZOPICLONE	138729-47-2	ESZOPICLONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485440	eszopiclone 1 MG Oral Tablet	PSN	50be8fdb-b97c-48fc-863f-878f3e9a3ec6	8
485440	eszopiclone 1 MG Oral Tablet	PSN	8bb1965e-7845-4c5b-b021-38e251303d68	8
485442	eszopiclone 2 MG Oral Tablet	PSN	8bb1965e-7845-4c5b-b021-38e251303d68	8
485465	eszopiclone 3 MG Oral Tablet	PSN	8bb1965e-7845-4c5b-b021-38e251303d68	8
485440	eszopiclone 1 MG Oral Tablet	SCD	50be8fdb-b97c-48fc-863f-878f3e9a3ec6	8
485440	eszopiclone 1 MG Oral Tablet	SCD	8bb1965e-7845-4c5b-b021-38e251303d68	8
485442	eszopiclone 2 MG Oral Tablet	SCD	8bb1965e-7845-4c5b-b021-38e251303d68	8
485465	eszopiclone 3 MG Oral Tablet	SCD	8bb1965e-7845-4c5b-b021-38e251303d68	8
485440	eszopiclone 1 MG Oral Tablet	PSN	1bbd525e-be06-310d-e054-00144ff88e88	3
485442	eszopiclone 2 MG Oral Tablet	PSN	1bbd525e-be06-310d-e054-00144ff88e88	3
485465	eszopiclone 3 MG Oral Tablet	PSN	1bbd525e-be06-310d-e054-00144ff88e88	3
485440	eszopiclone 1 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3
485442	eszopiclone 2 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3
485465	eszopiclone 3 MG Oral Tablet	SCD	1bbd525e-be06-310d-e054-00144ff88e88	3
485440	eszopiclone 1 MG Oral Tablet	PSN	b8cd6577-17e7-4808-a9a8-3f65444c51cb	2
485440	eszopiclone 1 MG Oral Tablet	SCD	b8cd6577-17e7-4808-a9a8-3f65444c51cb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-586-08	47335058608	100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08)	2014-04-15	0000-00-00	No	No	Current
47335-586-18	47335058618	1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18)	2014-04-15	0000-00-00	No	No	Current
47335-586-83	47335058683	30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83)	2014-04-15	0000-00-00	No	No	Current
47335-586-88	47335058688	100 TABLET, FILM COATED in 1 BOTTLE (47335-586-88)	2014-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESZOPICLONE	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
ESZOPICLONE	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2018-10-25	Human Prescription Drug Label	8
ESZOPICLONE	Unit Dose Services	2017-11-07	Human Prescription Drug Label	8
ESZOPICLONE	DIRECT RX	2015-08-10	HUMAN PRESCRIPTION DRUG LABEL	2

ESZOPICLONE

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#