FDA.reportPublic FDA data

Lunesta

Product NDC
63402-193
11-digit product format
634020193
Labeler code
63402
Product ID
63402-193_4c2704d7-3027-4240-9073-3f0b24cf15b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sunovion Pharmaceuticals Inc.
Application
NDA021476
Marketing category
NDA
Marketing start
2005-04-04
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63402-193-032021-09-13C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f
63402-193-102021-09-13C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f
63402-193-302021-09-13C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f
63402-193-032021-07-23C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f
63402-193-102021-07-23C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f
63402-193-302021-07-23C16284748780-1c7ccaba7-1c20-fd44-e053-dadaa90aa01bfd047b2b-05a6-4d99-95cb-955f14bf329f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-193-03EA - Each63402-193eabc03c7-323e-4359-b561-ff3404694e5e12018-12-13
63402-193-10EA - Each63402-1932629e041-d4e2-4664-8ab5-35947d55c0ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [SUNOVION PHARMACEUTICALS INC.]19
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
eszopicloneACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
eszopicloneACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63402-193LUNESTA (ESZOPICLONE) TABLET, COATED [SUMITOMO PHARMA AMERICA, INC.]31Legacy NDC20231212_fd047b2b-05a6-4d99-95cb-955f14bf329f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
485442eszopiclone 2 MG Oral TabletPSN1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
485442eszopiclone 2 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
485465eszopiclone 3 MG Oral TabletPSN1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
485465eszopiclone 3 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
540407Lunesta 1 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
540409Lunesta 2 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
540409Lunesta 2 MG Oral TabletPSN1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
540411Lunesta 3 MG Oral TabletPSN5e5929f1-bdd9-4001-b542-b83de39540ec3
540411Lunesta 3 MG Oral TabletPSN1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
540407eszopiclone 1 MG Oral Tablet [Lunesta]SBD5e5929f1-bdd9-4001-b542-b83de39540ec3
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD5e5929f1-bdd9-4001-b542-b83de39540ec3
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD5e5929f1-bdd9-4001-b542-b83de39540ec3
485440eszopiclone 1 MG Oral TabletSCD5e5929f1-bdd9-4001-b542-b83de39540ec3
485442eszopiclone 2 MG Oral TabletSCD5e5929f1-bdd9-4001-b542-b83de39540ec3
485442eszopiclone 2 MG Oral TabletSCD1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
485465eszopiclone 3 MG Oral TabletSCD1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
485465eszopiclone 3 MG Oral TabletSCD5e5929f1-bdd9-4001-b542-b83de39540ec3
540407Lunesta 1 MG Oral TabletSY5e5929f1-bdd9-4001-b542-b83de39540ec3
540409Lunesta 2 MG Oral TabletSY1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
540409Lunesta 2 MG Oral TabletSY5e5929f1-bdd9-4001-b542-b83de39540ec3
540411Lunesta 3 MG Oral TabletSY5e5929f1-bdd9-4001-b542-b83de39540ec3
540411Lunesta 3 MG Oral TabletSY1f468b3f-7edf-44aa-81e2-ddb1cc0c17243
485442eszopiclone 2 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
485442eszopiclone 2 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485465eszopiclone 3 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485465eszopiclone 3 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540409Lunesta 2 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540409Lunesta 2 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540411Lunesta 3 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411Lunesta 3 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD7b069c49-007c-4f77-878c-0a6c564e27171
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD7b069c49-007c-4f77-878c-0a6c564e27171
485442eszopiclone 2 MG Oral TabletSCD7b069c49-007c-4f77-878c-0a6c564e27171
485442eszopiclone 2 MG Oral TabletSCD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485465eszopiclone 3 MG Oral TabletSCD7b069c49-007c-4f77-878c-0a6c564e27171
485465eszopiclone 3 MG Oral TabletSCD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540409Lunesta 2 MG Oral TabletSY7b069c49-007c-4f77-878c-0a6c564e27171
540409Lunesta 2 MG Oral TabletSY20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411Lunesta 3 MG Oral TabletSY20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411Lunesta 3 MG Oral TabletSY7b069c49-007c-4f77-878c-0a6c564e27171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63402-193-036340201930330 TABLET, COATED in 1 BOTTLE (63402-193-03) 2018-11-010000-00-00NoNoCurrent
63402-193-1063402019310100 TABLET, COATED in 1 BOTTLE (63402-193-10) 2005-04-040000-00-00NoNoCurrent