FDA.reportPublic FDA data

Mexiletine Hydrochloride

Product NDC
0093-8739
11-digit product format
000938739
Labeler code
0093
Product ID
0093-8739_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074377
Marketing category
ANDA
Marketing start
1995-06-05
Substance
MEXILETINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mexiletine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEXILETINE HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii606D60IS38
Rxcui1362706, 1362712, 1362720

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8739-01Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8739-01EA - Each0093-8739421d6b72-e15d-4b4b-84bf-a0196a33d28e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]6
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MEXILETINE HYDROCHLORIDEACTIVE INGREDIENT606D60IS38MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MEXILETINEACTIVE MOIETY1U511HHV4ZMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]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. 1INACTIVE INGREDIENTH3R47K3TBDMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEXILETINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]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
0093-8739MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 1 package rows20230630_693da40b-26d4-40d6-87d1-158e256f40ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362712mexiletine HCl 200 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362720mexiletine HCl 250 MG Oral CapsulePSN693da40b-26d4-40d6-87d1-158e256f40ab11
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCD693da40b-26d4-40d6-87d1-158e256f40ab11
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
1362706mexiletine HCl 150 MG Oral CapsulePSN25b8c89e-450c-4a1d-9053-1eb97b868a983
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD25b8c89e-450c-4a1d-9053-1eb97b868a983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8739-0100093873901100 CAPSULE in 1 BOTTLE (0093-8739-01) 100 capsule1995-06-050000-00-00NoNoCurrent