MEXILETINE HYDROCHLORIDE

Product NDC
63629-9180
11-digit product format
636299180
Labeler code
63629
Product ID
63629-9180_8783d6c1-d71c-49ea-b1be-4181f9ab06aa
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
63629-9180-1MEXILETINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9180-1EA - Each63629-91804caffcac-2f4a-4fc4-a2d4-b6ff1161ea4312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9180MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231025_41930321-15e3-4ddf-ba5d-3655ce5f2923.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362712mexiletine HCl 200 MG Oral CapsulePSN41930321-15e3-4ddf-ba5d-3655ce5f2923102
1362712mexiletine hydrochloride 200 MG Oral CapsuleSCD41930321-15e3-4ddf-ba5d-3655ce5f2923102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9180-163629918001100 CAPSULE in 1 BOTTLE (63629-9180-1) 100 capsule2022-02-220000-00-00NoNoCurrent