Mexiletine Hydrochloride

Product NDC
68151-2347
11-digit product format
681512347
Labeler code
68151
Product ID
68151-2347_bd6eb1b5-511e-45e0-984b-9b93233dbf2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA074377
Marketing category
ANDA
Marketing start
1995-06-05
Marketing end
0000-00-00
Substance
MEXILETINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
497452b0-11f5-0347-7928-e7d06bb38077Product name420230426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2347-02020-01-31C16284748780-19d75b9d0-4732-f424-e053-dadaa90a57ceMEXILETINE HYDROCHLORIDE CAPSULES USP 8739 8740 8741 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2347-0Mexiletine Hydrochloride1 in 1 PACKAGECAPSULE12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2347MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140708_402b3836-89de-4468-8266-8910430d0053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362712mexiletine HCl 200 MG Oral CapsulePSN402b3836-89de-4468-8266-8910430d00532
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD402b3836-89de-4468-8266-8910430d00532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2347-0681512347001 in 1 PACKAGEHistorical