MEXILETINE HYDROCHLORIDE

Product NDC
71335-2928
11-digit product format
713352928
Labeler code
71335
Product ID
71335-2928_59bf343f-e466-410a-9918-43a88bc817a4
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
497452b0-11f5-0347-7928-e7d06bb38077Product name420230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2928-1MEXILETINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2928-1EA - Each71335-292868708db3-b2c7-40b3-8cb1-d058c7cd5a7b12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362712mexiletine HCl 200 MG Oral CapsulePSN68987377-c7c2-493b-be42-30379ec432bc100
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD68987377-c7c2-493b-be42-30379ec432bc100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2928-171335292801100 CAPSULE in 1 BOTTLE (71335-2928-1) 100 capsule2025-11-06NoNoCurrent