MEXILETINE HYDROCHLORIDE

Product NDC
72162-1782
11-digit product format
721621782
Labeler code
72162
Product ID
72162-1782_8dbdfa77-0dbe-4598-bca6-bc4c69d1fdda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mexiletine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214089
Marketing category
ANDA
Marketing start
2021-11-29
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

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
72162-1782-1MEXILETINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1782-1EA - Each72162-178273e0edc2-3893-4fe5-becd-ab937d5d9bac12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1782MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240809_6cd564bd-24e3-481b-b998-f69f65d67fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN6cd564bd-24e3-481b-b998-f69f65d67fbe102
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD6cd564bd-24e3-481b-b998-f69f65d67fbe102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1782-172162178201100 CAPSULE in 1 BOTTLE (72162-1782-1) 100 capsule2024-04-04NoNoCurrent