Basic Information
Tramadol Hydrochloride and Acetaminophen
68788-7855
Regulatory Information
68788-7855
ANDA090485
C73584
October 2, 2023
USA
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-IVInitial U.S. Approval: 2001
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
791119022
Active Ingredients
CARNAUBA WAX
Code: R12CBM0EIZ
Class Code: IACT
CROSPOVIDONE (35 .MU.M)
Code: 40UAA97IT9
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
TRAMADOL
Code: 39J1LGJ30J
ACETAMINOPHEN
Code: 362O9ITL9D