Rozerem
Approved
Approval ID
7a51d289-2013-4d37-adf2-91ea49df7932
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5649
Application NumberNDA021782
Product Classification
M
Marketing Category
C73594
G
Generic Name
ramelteon
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2010
FDA Product Classification
INGREDIENTS (12)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
RAMELTEONActive
Quantity: 8 mg in 1 1
Code: 901AS54I69
Classification: ACTIB