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 97 of 132 · 2,623 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TiZO Mineral Stick Non-Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	e7044f18-992a-4f60-9a2b-f11ed06db09b	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
CoTZ Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	479a7d82-a068-4c2e-b50b-555c40e13e37	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	e17a8c35-2d49-4c99-b154-ea673c14753e	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light Medium	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	1af6184e-3dc4-4eb3-8d51-aca724473451	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	77d77838-aa13-4939-a1a0-50189fbb3fe0	2024-10-25	Warnings	Exact identifier unii: 15FIX9V2JP
FATIGUE NOSODE EB	ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODE	Energique, Inc.	36d963cc-fd47-40ee-aa73-c2e7fcedf192	2024-10-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Complexion HP	CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM	Energique, Inc.	ad12d51e-04cb-4833-b802-0038796966ff	2024-10-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffbb6af-5a04-f58a-e053-2995a90a1ae2	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Banana Boat	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands, LLC	441a46f0-ecda-4448-e054-00144ff88e88	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cffb8219-7076-de64-e053-2a95a90a6036	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Rare Beauty, LLC	cfee02eb-92f9-be12-e053-2a95a90a4337	2024-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
CVS Health 60 Plus Sensitive Skin Sun	TITANIUM DIOXIDE, ZINC OXIDE	CVS Pharmacy	477c25ec-33db-04a6-e054-00144ff8d46c	2024-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bali Body Tinted Super Serum Natural SPF 30	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Bali Body Pty Ltd	f5eeaf37-33f2-2c0c-e053-2a95a90abcc0	2024-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f42a0b1e-038d-4fab-e053-2995a90a5364	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f4481bf3-6dc7-5641-e053-2a95a90ad938	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fruit Of The Earth, Inc.	f45d25d2-9305-5858-e053-2a95a90a7f7b	2024-10-18	Warnings	Exact identifier unii: 15FIX9V2JP
SPF50 Plus Mineral Sunscreen	ZINC OXIDE AND TITANIUM DIOXIDE	KAS Direct LLC dba BabyGanics	08e8bc10-85d8-4215-8351-7ec12029416c	2024-10-17	Warnings	Exact identifier unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	WEGMANS FOOD MARKETS INC	bfe24f55-d0e5-254a-e053-2995a90a2fd3	2024-10-16	Warnings	Exact identifier unii: 15FIX9V2JP
Equate Sunscreen SPF 50 KIDS Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	WAL-MART STORES INC	81cb6b2e-1ca3-4a83-a8df-9bfee61e79af	2024-10-16	Warnings	Exact identifier unii: 15FIX9V2JP
MINERAL BASED SPF 50 SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	THE KROGER COMPANY	a4e6936d-a76c-e8fd-e053-2995a90a965f	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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