Dexmethylphenidate Hydrochloride

Basic Information

Product Name

FDA Product Code

49884-539

Regulatory Information

NDC Product Code

49884-539

Application Number

ANDA202842

Marketing Category

C73584

Effective Date

October 5, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for Oral Use CIIInitial U.S. Approval: 2001

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Quantity: 30 mg in 1 1

Code: 1678OK0E08

Class Code: ACTIB

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

Code: NX76LV5T8J

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

1-PROPOXY-2-PROPANOL

Code: 152BY1743W

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties