MEXILETINE HYDROCHLORIDE

Product NDC
72162-1783
11-digit product format
721621783
Labeler code
72162
Product ID
72162-1783_59f978d8-bfa3-4f24-8d3f-7e3ff0741954
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
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii606D60IS38
Rxcui1362712

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
72162-1783-1MEXILETINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1783-1EA - Each72162-178304eb2f1c-b7b7-4da4-b6db-f6b8eb3464de12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1783MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240602_2f4239ef-a28a-40d3-9617-2029d492829d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362712mexiletine HCl 200 MG Oral CapsulePSN2f4239ef-a28a-40d3-9617-2029d492829d102
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD2f4239ef-a28a-40d3-9617-2029d492829d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1783-172162178301100 CAPSULE in 1 BOTTLE (72162-1783-1) 100 capsule2024-04-04NoNoHistorical