Basic Information
CONCERTA
50458-586
Regulatory Information
50458-586
NDA021121
C73594
October 27, 2023
USA
These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 2000
HUMAN PRESCRIPTION DRUG LABEL
26
Company Information
063137772
Active Ingredients
CARNAUBA WAX
Code: R12CBM0EIZ
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
BUTYLATED HYDROXYTOLUENE
Code: 1P9D0Z171K
Class Code: IACT
LACTOSE, UNSPECIFIED FORM
Code: J2B2A4N98G
Class Code: IACT
PHOSPHORIC ACID
Code: E4GA8884NN
Class Code: IACT
SODIUM CHLORIDE
Code: 451W47IQ8X
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
POVIDONE, UNSPECIFIED
Code: FZ989GH94E
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
SUCCINIC ACID
Code: AB6MNQ6J6L
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
CELLULOSE ACETATE
Code: 3J2P07GVB6
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
Active Moieties
METHYLPHENIDATE
Code: 207ZZ9QZ49