Edluar
These highlights do not include all the information needed to use EDLUAR safely and effectively. See full prescribing information for EDLUAR. EDLUAR (zolpidem tartrate) sublingual tablets, for oral use, CIVInitial U.S. Approval: 1992
Approved
Approval ID
a32884d0-85b5-11de-8a39-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2022
Manufacturers
FDA
Meda Pharmaceuticals Inc.
DUNS: 051229602
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zolpidem Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-6050
Application NumberNDA021997
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (7)
ZOLPIDEM TARTRATEActive
Quantity: 5 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Zolpidem Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-6010
Application NumberNDA021997
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolpidem Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2021
FDA Product Classification
INGREDIENTS (7)
ZOLPIDEM TARTRATEActive
Quantity: 10 mg in 1 1
Code: WY6W63843K
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT