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 4 of 135 · 2,685 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12	SILICEA	Zettl Health Inc.	5647dafc-1fff-6a25-e063-6294a90a8b4f	2026-07-10		Exact identifier unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP
EELHOE Body Coverage Perfector	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5610c3b7-456b-3bc1-e063-6394a90a3fa8	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Emerald Aesthetics LLC	55f88dd1-346c-22a5-e063-6294a90a711f	2026-07-06	Warnings	Exact identifier unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	LG H&H Co., Ltd.	d307471c-6cc6-ce48-e053-2995a90a3e02	2026-07-02	Warnings	Exact identifier unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Eden Brands Inc.	2cb7773f-9a05-ad02-e063-6294a90af024	2026-07-01	Warnings	Exact identifier unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	The Cell Salt Company LLC	55826f59-acf4-7370-e063-6394a90afed7	2026-07-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	LG H&H Co., Ltd.	d2f9c54b-ac4e-5141-e053-2a95a90aa2b8	2026-06-30	Warnings	Exact identifier unii: 15FIX9V2JP
Bambusa Stannum	BAMBUSA STANNUM	Uriel Pharmacy Inc.	a0d4d0ac-e2d2-4381-8f93-e41719521859	2026-06-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton Blue	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	PICTON Co., Ltd.	4d6ddee3-9a76-6c9c-e063-6394a90a1529	2026-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30	SUNSCREEN	Earth Baby, Inc.	42556876-74ea-38e6-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
Sun Does Matter Daily Face Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	Sundoesmatter Company Inc.	553687d8-d4e1-8361-e063-6294a90a24fe	2026-06-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f25ba-61d5-6a94-e063-6394a90a46e9	2026-06-26	Warnings	Exact identifier unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f4799-9122-8db5-e063-6394a90a5132	2026-06-26	Warnings	Exact identifier unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f6d2c-9b8c-aa52-e063-6294a90a787e	2026-06-26	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rocky Mountain	5515f562-62d9-c6ee-e063-6294a90a9ea6	2026-06-25	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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