Mexiletine Hydrochloride

Product NDC
63629-2145
11-digit product format
636292145
Labeler code
63629
Product ID
63629-2145_0151c57d-79e6-4416-a9b1-6f34fe442096
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
150 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 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
63629-2145-1Mexiletine Hydrochloride100 in 1 BOTTLECAPSULE100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2145-1EA - Each63629-21455ec896f0-d505-4626-af9c-b7959edbe0f212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2145MEXILETINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_c09f68fa-759e-4772-9f6b-11005d8f83d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSNc09f68fa-759e-4772-9f6b-11005d8f83d5103
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCDc09f68fa-759e-4772-9f6b-11005d8f83d5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2145-163629214501100 CAPSULE in 1 BOTTLE (63629-2145-1) 100 capsule2021-02-080000-00-00NoNoCurrent