FDA.reportPublic FDA data

Mexiletine Hydrochloride

Product NDC
42291-625
11-digit product format
422910625
Labeler code
42291
Product ID
42291-625_4870f872-0804-7f08-e063-6394a90a19e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA074377
Marketing category
ANDA
Marketing start
2013-07-09
Substance
MEXILETINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mexiletine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEXILETINE HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii606D60IS38
Rxcui1362706, 1362712, 1362720

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
497452b0-11f5-0347-7928-e7d06bb38077Product name420230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-625-01Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-625-01EA - Each42291-625553c33fb-bc86-4c4f-b1a1-be2e6f99059912013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-625MEXILETINE HYDROCHLORIDE CAPSULE [AVKARE]8Current NDC, Legacy NDC, 1 package rows20230511_c528aae3-ff51-b9e4-a401-4ef5910e4b43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362712mexiletine HCl 200 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362720mexiletine HCl 250 MG Oral CapsulePSNc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCDc528aae3-ff51-b9e4-a401-4ef5910e4b439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-625-0142291062501100 CAPSULE in 1 BOTTLE (42291-625-01) 100 capsule2013-07-090000-00-00NoNoCurrent