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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63402-193DDiscontinued by firm2026-08-11
excluded packagepackage63402-19363402-193-03DDiscontinued by firm2026-08-11
excluded packagepackage63402-19363402-193-10DDiscontinued by firm2026-08-11
excluded packagepackage63402-19363402-193-30DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63402-193-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63402-193-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63402-193-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63402-193-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63402-193-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63402-193-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63402-193-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63402-193-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63402-193-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63402-193-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63402-193-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63402-193-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63402-193-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63402-193-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63402-193-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63402-193-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63402-193-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63402-193-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63402-193-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63402-193-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63402-193-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63402-193-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63402-193-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63402-193-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63402-193-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63402-193-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021476-001LUNESTAESZOPICLONE1MGTABLET / ORALABRLD2004-12-15
N021476-002LUNESTAESZOPICLONE2MGTABLET / ORALABRLD2004-12-15
N021476-003LUNESTAESZOPICLONE3MGTABLET / ORALABRLD, RS2004-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021476-001AB
N021476-002AB
N021476-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-002LUNESTA2MGTABLET / ORALABRLD2004-12-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-003LUNESTA3MGTABLET / ORALABRLD, RS2004-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021476-001LUNESTA1MGTABLET / ORALABRLD2004-12-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021476-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021476-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021476-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021476-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021476-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021476-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021476-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021476-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021476-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021476-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021476-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021476-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021476-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021476-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021476-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021476-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021476-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021476-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021476-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021476-001AB18072bd15b7f6…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63402-193-032021-09-13These 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
63402-193-102021-09-13These 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
63402-193-302021-09-13These 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
63402-193-032021-07-23These 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
63402-193-102021-07-23These 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
63402-193-302021-07-23These 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 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 [PD-RX PHARMACEUTICALS, INC.]8
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]8
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 [H.J. HARKINS COMPANY, INC.]3
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, 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 [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, 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 [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, 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 [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]3
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [BRYANT RANCH PREPACK]2
eszopicloneACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
eszopicloneACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]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 [DISPENSING SOLUTIONS, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]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 [DISPENSING SOLUTIONS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]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 [DISPENSING SOLUTIONS, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LunestaESZOPICLONEWaylis Therapeutics LLC3821f4b7-a3c8-4920-ba80-18aa96532c092025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021476
application number: NDA021476

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