TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001
Approved
Approval ID
52757002-ad65-41ed-bad0-8236a4929419
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
PRODUCT DETAILS
NDC Product Code57664-537
Application NumberANDA077184
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 15, 2024
Generic NameTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB