Lunesta
LUNESTA (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg
Approved
Approval ID
7b069c49-007c-4f77-878c-0a6c564e2717
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eszopiclone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-226
Application NumberNDA021476
Product Classification
M
Marketing Category
C73594
G
Generic Name
eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2009
FDA Product Classification
INGREDIENTS (12)
eszopicloneActive
Quantity: 3 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
eszopiclone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-225
Application NumberNDA021476
Product Classification
M
Marketing Category
C73594
G
Generic Name
eszopiclone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2009
FDA Product Classification
INGREDIENTS (11)
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
eszopicloneActive
Quantity: 2 mg in 1 1
Code: UZX80K71OE
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT