Methylphenidate Hydrochloride

Basic Information

Product Name

FDA Product Code

42858-080

Regulatory Information

NDC Product Code

42858-080

Application Number

NDA205831

Marketing Category

C73605

Effective Date

October 31, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Capsules Methylphenidate Hydrochloride Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1955

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Methylphenidate Hydrochloride

Quantity: 50 mg in 1 1

Code: 4B3SC438HI

Class Code: ACTIB

Inactive Ingredients

Starch, corn

Code: O8232NY3SJ

Class Code: IACT

Sucrose

Code: C151H8M554

Class Code: IACT

Triethyl citrate

Code: 8Z96QXD6UM

Class Code: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

Code: NX76LV5T8J

Class Code: IACT

Hypromellose, unspecified

Code: 3NXW29V3WO

Class Code: IACT

Polyethylene glycol, unspecified

Code: 3WJQ0SDW1A

Class Code: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE B

Code: 161H3B14U2

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Silicon dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Gelatin, unspecified

Code: 2G86QN327L

Class Code: IACT

FD&C Green No. 3

Code: 3P3ONR6O1S

Class Code: IACT

D&C Yellow No. 10

Code: 35SW5USQ3G

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Potassium hydroxide

Code: WZH3C48M4T

Class Code: IACT

Ferrosoferric oxide

Code: XM0M87F357

Class Code: IACT

Active Moieties