Mexiletine Hydrochloride

Product NDC
72162-1773
11-digit product format
721621773
Labeler code
72162
Product ID
72162-1773_960f7e70-bd20-401c-8a62-b06570a05947
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
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii606D60IS38
Rxcui1362712

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
72162-1773-1Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1773-1EA - Each72162-17739ddd5af5-efb1-485b-b9c6-9c406698677612024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1773MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240208_a0bd3f2c-44e5-4ad0-9b76-c2028f0cae11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362712mexiletine HCl 200 MG Oral CapsulePSNa0bd3f2c-44e5-4ad0-9b76-c2028f0cae11101
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCDa0bd3f2c-44e5-4ad0-9b76-c2028f0cae11101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1773-172162177301100 CAPSULE in 1 BOTTLE (72162-1773-1) 100 capsule2026-03-25NoNoHistorical