Ramelteon
These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS. RAMELTEON tablets, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
7f19c83a-4da3-4bb1-aae9-db0ec29175b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
Manufacturers
FDA
Westminster Pharmaceuticals, LLC
DUNS: 079516651
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ramelteon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-356
Application NumberANDA215435
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramelteon
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
RAMELTEONActive
Quantity: 8 mg in 1 1
Code: 901AS54I69
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT