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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-776
Application NumberANDA213186
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramelteon
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
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