Mexiletine Hydrochloride

Product NDC
72162-1772
11-digit product format
721621772
Labeler code
72162
Product ID
72162-1772_775d6763-ba90-4d29-8e76-fa0aec1877ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074450
Marketing category
ANDA
Marketing start
2020-06-22
Substance
MEXILETINE HYDROCHLORIDE
Active strength
150 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 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
72162-1772-1Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1772-1EA - Each72162-1772238c669d-38bb-4756-93c7-ac3f7ee376a012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1772MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240208_9c2e1055-2fa1-462c-90f3-6d77e89ea38a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN9c2e1055-2fa1-462c-90f3-6d77e89ea38a101
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD9c2e1055-2fa1-462c-90f3-6d77e89ea38a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1772-172162177201100 CAPSULE in 1 BOTTLE (72162-1772-1) 100 capsule2026-03-26NoNoHistorical