Basic Information
TRAMADOL HYDROCHLORIDE
71610-398
Regulatory Information
71610-398
ANDA091498
C73584
March 10, 2020
USA
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS. TRAMADOL HYDROCHLORIDE tablets, for oral use, CIVInitial U.S. Approval: 1995
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
Active Ingredients
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
Active Moieties
TRAMADOL
Code: 39J1LGJ30J