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
46bb9ae6-3ee8-463c-badb-c7a45a89b84b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRAMADOL HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code68180-699
Application NumberANDA200503
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 16, 2024
Generic NameTRAMADOL HYDROCHLORIDE
INGREDIENTS (10)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRAMADOL HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code68180-697
Application NumberANDA200503
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 16, 2024
Generic NameTRAMADOL HYDROCHLORIDE
INGREDIENTS (10)
TRAMADOL HYDROCHLORIDEActive
Quantity: 100 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
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TRAMADOL HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code68180-698
Application NumberANDA200503
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 16, 2024
Generic NameTRAMADOL HYDROCHLORIDE
INGREDIENTS (10)
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT