Basic Information
TRAMADOL HYDROCHLORIDE
71335-1675
Regulatory Information
71335-1675
ANDA201384
C73584
June 30, 2021
USA
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
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
171714327
Active Ingredients
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CELLULOSE ACETATE
Code: 3J2P07GVB6
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
Active Moieties
TRAMADOL
Code: 39J1LGJ30J