TRAMADOL HCL 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
774b7307-147c-43b9-a39a-63059167f295
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2020
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRAMADOL HCL AND ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-049
Application NumberANDA076914
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HCL AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2020
FDA Product Classification
INGREDIENTS (14)
TRAMADOL HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT