TRAMADOL HYDROCHLORIDE
These highlights do not include all the information needed to use children who developed life-threatening respiratory depression or died after taking tramadol for pain relief 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 IV Initial U.S. Approval: 1995
Approved
Approval ID
a77b0dba-8ac7-418a-b435-16a0e6c22804
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
NDC Product Code63629-8324
Application NumberANDA201384
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2022
Generic NameTRAMADOL HYDROCHLORIDE
INGREDIENTS (12)
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT