MedPath
FDA Product

CONCERTA

Product approved by U.S. Food and Drug Administration (US)

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

METHYLPHENIDATE HYDROCHLORIDE

Quantity: 36 mg in 1 1

Code: 4B3SC438HI

Class Code: ACTIB

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

METHYLPHENIDATE

Code: 207ZZ9QZ49

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