MEXILETINE HYDROCHLORIDE

Product NDC
63629-9179
11-digit product format
636299179
Labeler code
63629
Product ID
63629-9179_932c6d53-8690-4039-aff0-3f6e829f5bd1
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
150 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 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
63629-9179-1MEXILETINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9179-1EA - Each63629-917996b27a63-00b8-4206-b412-dee5c464f35512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9179MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240509_9099b620-eae9-48f9-9d5f-8fd22c32b2b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN9099b620-eae9-48f9-9d5f-8fd22c32b2b0103
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD9099b620-eae9-48f9-9d5f-8fd22c32b2b0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9179-163629917901100 CAPSULE in 1 BOTTLE (63629-9179-1) 100 capsule2024-04-040000-00-00NoNoCurrent