TRAMADOL HYDROCHLORIDE
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IVInitial U.S. Approval: 1995
Approved
Approval ID
68484531-f908-473f-a422-f37234de9691
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2023
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRAMADOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83008-009
Application NumberANDA200503
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2023
FDA Product Classification
INGREDIENTS (10)
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT