Mexiletine Hydrochloride

Product NDC
51407-381
11-digit product format
514070381
Labeler code
51407
Product ID
51407-381_45b6d529-143e-2322-e063-6294a90a65a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074450
Marketing category
ANDA
Marketing start
1996-05-16
Substance
MEXILETINE HYDROCHLORIDE
Active strength
250 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 HYDROCHLORIDE250 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
51407-381-01Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-381-01EA - Each51407-381d15c82df-50f7-4fb7-a61f-bbfeb92f795412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-381MEXILETINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, Legacy NDC, 1 package rows20230325_bfe2b847-e18d-cef2-e053-2995a90a42af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSNbfe2b847-e18d-cef2-e053-2995a90a42af3
1362712mexiletine HCl 200 MG Oral CapsulePSNbfe2b847-e18d-cef2-e053-2995a90a42af3
1362720mexiletine HCl 250 MG Oral CapsulePSNbfe2b847-e18d-cef2-e053-2995a90a42af3
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCDbfe2b847-e18d-cef2-e053-2995a90a42af3
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCDbfe2b847-e18d-cef2-e053-2995a90a42af3
1362720mexiletine hydrochloride 250 MG Oral CapsuleSCDbfe2b847-e18d-cef2-e053-2995a90a42af3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-381-0151407038101100 CAPSULE in 1 BOTTLE (51407-381-01) 100 capsule2020-12-180000-00-00NoNoCurrent