Lunesta

Product NDC
21695-225
11-digit product format
216950225
Labeler code
21695
Product ID
21695-225_7b069c49-007c-4f77-878c-0a6c564e2717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eszopiclone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021476
Marketing category
NDA
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-225-302019-09-24C16284748780-1934fe258-4c83-48b1-e053-8cdaa90a720aLUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-225-30Lunesta30 in 1 BOTTLETABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-225-30EA - Each21695-2257ee214d5-390b-47ac-92ce-e24b964add8312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
eszopicloneACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
eszopicloneACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]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
magnesium stearateINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1
triacetinINACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-225LUNESTA (ESZOPICLONE) TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101201_7b069c49-007c-4f77-878c-0a6c564e2717.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
485465eszopiclone 3 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540409Lunesta 2 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540411Lunesta 3 MG Oral TabletPSN7b069c49-007c-4f77-878c-0a6c564e27171
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD7b069c49-007c-4f77-878c-0a6c564e27171
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD7b069c49-007c-4f77-878c-0a6c564e27171
485442eszopiclone 2 MG Oral TabletSCD7b069c49-007c-4f77-878c-0a6c564e27171
485465eszopiclone 3 MG Oral TabletSCD7b069c49-007c-4f77-878c-0a6c564e27171
540409Lunesta 2 MG Oral TabletSY7b069c49-007c-4f77-878c-0a6c564e27171
540411Lunesta 3 MG Oral TabletSY7b069c49-007c-4f77-878c-0a6c564e27171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-225-302169502253030 in 1 BOTTLEHistorical