LISDEXAMFETAMINE DIMESYLATE

Basic Information

Product Name

FDA Product Code

43602-308

Regulatory Information

NDC Product Code

43602-308

Application Number

ANDA217442

Marketing Category

C73584

Effective Date

August 28, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use LISDEXAMFETAMINE DIMESYLATE CAPSULES safely and effectively. See full prescribing information for LISDEXAMFETAMINE DIMESYLATE CAPSULES. LISDEXAMFETAMINE DIMESYLATE capsules, for oral use, CII Initial U.S. Approval: 2007

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LISDEXAMFETAMINE DIMESYLATE

Quantity: 30 mg in 1 1

Code: SJT761GEGS

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties