NDC 63402-191-01 - Lunesta

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63402-191
Requested NDC: 63402-191-01
Package NDCs from labels: 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30
Manufacturer: Sumitomo Pharma America, Inc.
Effective date: 2023-12-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lunesta - Sumitomo Pharma America, Inc.	Sumitomo Pharma America, Inc.	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	Physicians Total Care, Inc.	2012-04-18	HUMAN PRESCRIPTION DRUG LABEL
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL
LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg	Dispensing Solutions, Inc.	2011-10-10	HUMAN PRESCRIPTION DRUG LABEL
Lunesta - Rebel Distributors Corp	Rebel Distributors Corp	2010-10-01	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63402-191-03	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-10	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-30	2021-09-13	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-03	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-10	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004
63402-191-30	2021-07-23	These highlights do not include all the information needed to use LUNESTA safely and effectively. See full prescribing information for LUNESTA. LUNESTA ® (eszopiclone) tablets, for oral use, C IV Initial U.S. Approval: 2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63402-191	LUNESTA (ESZOPICLONE) TABLET, COATED [SUMITOMO PHARMA AMERICA, INC.]	31	Legacy NDC	20231212_fd047b2b-05a6-4d99-95cb-955f14bf329f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-191-03	EA - Each	63402-191	402a6ef7-dc74-4e54-a470-4ec9d89c3967	1	2018-12-13
63402-191-10	EA - Each	63402-191	9bb7d8e5-0992-4a38-954b-cd8acc6433f4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]	19
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]	3
eszopiclone	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
ESZOPICLONE	ACTIVE INGREDIENT	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
ESZOPICLONE	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
eszopiclone	ACTIVE MOIETY	UZX80K71OE	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
Anhydrous Dibasic Calcium Phosphate	INACTIVE INGREDIENT	L11K75P92J	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 43 of 135 · 2,685 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb8ee19-81b2-daed-e063-6394a90a0fb3	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	35442ac0-c361-e08f-e063-6294a90a5cb2	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3543e85d-9bc7-b8ed-e063-6294a90ae7d3	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Essential Brazilian Spa LLC	3bc8593d-fc6c-04aa-e063-6394a90a6d56	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Mantra Wellness Spa	3389b0a3-40f9-b411-e063-6394a90a9959	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	39959db9-5ee1-a27c-e063-6394a90a1e10	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3995f556-20fe-3e64-e063-6294a90a5efe	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3995385b-b10b-ca5c-e063-6294a90af43f	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	3994aa84-30b4-3dc4-e063-6394a90a23e7	2025-12-15		Exact identifier unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILESTHETICS LLC	39947913-f1cc-25d2-e063-6294a90a4229	2025-12-15		Exact identifier unii: 15FIX9V2JP
Solar Shield Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DENISE BELL SKIN CARE	396eb781-5947-3665-e063-6294a90a38dd	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Primer tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	3542d8d3-35a3-7d63-e063-6394a90a6fd1	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	354357de-1a85-3bdb-e063-6294a90aa9a2	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Primer tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	35433254-1dc8-a8f3-e063-6394a90a29f0	2025-12-15		Exact identifier unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357eee3c-1c21-5efb-e063-6294a90a4bb7	2025-12-15		Exact identifier unii: 15FIX9V2JP
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357e75ec-473e-df76-e063-6294a90a70c7	2025-12-15		Exact identifier unii: 15FIX9V2JP
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f2f62-904a-2234-e063-6394a90aee72	2025-12-15		Exact identifier unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357ff025-84ad-6d77-e063-6394a90aad95	2025-12-15		Exact identifier unii: 15FIX9V2JP
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	358021a2-235b-825b-e063-6394a90a76f5	2025-12-15		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.