TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Rx only
Approved
Approval ID
e5914c36-ff79-4fad-b454-4414443cc230
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-569
Application NumberANDA077184
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (12)
TRAMADOL HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
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
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT