Dexmethylphenidate Hydrochloride

Basic Information

Product Name

FDA Product Code

63629-9468

Regulatory Information

NDC Product Code

63629-9468

Application Number

ANDA212631

Marketing Category

C73584

Effective Date

September 9, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

101

Active Ingredients

DEXMETHYLPHENIDATE HYDROCHLORIDE

Quantity: 2.5 mg in 1 1

Code: 1678OK0E08

Class Code: ACTIB

Inactive Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties