MedPath
FDA Product

MEXILETINE HYDROCHLORIDE

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

Basic Information

MEXILETINE HYDROCHLORIDE

69315-236

Regulatory Information

69315-236

ANDA215876

C73584

March 1, 2023

USA

Mexiletine Hydrochloride Capsules, USPRx only

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

079575060

Active Ingredients

MEXILETINE HYDROCHLORIDE

Quantity: 150 mg in 1 1

Code: 606D60IS38

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

MEXILETINE

Code: 1U511HHV4Z

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