Ramelteon
RAMELTEON Tablets Rx Only These highlights do not include all the information needed to use RAMELTEON TABLETS safely and effectively. See full prescribing information for RAMELTEON TABLETS . Initial U.S. Approval: 2005
Approved
Approval ID
b6fc0db5-c68f-5af9-e053-2a95a90a5110
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ramelteon
PRODUCT DETAILS
NDC Product Code42291-776
Application NumberANDA213186
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 10, 2024
Generic NameRamelteon
INGREDIENTS (9)
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RAMELTEONActive
Quantity: 8 mg in 1 1
Code: 901AS54I69
Classification: ACTIB