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
32c52e03-4c2e-4774-9397-f1f0ee99b320
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
i3 Pharmaceuticals, LLC
DUNS: 080127275
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 Code72319-005
Application NumberANDA212650
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ramelteon
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
RAMELTEONActive
Quantity: 8 mg in 1 1
Code: 901AS54I69
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT