FDA.reportPublic FDA data

Mexiletine hydrochloride

Product NDC
60687-778
11-digit product format
606870778
Labeler code
60687
Product ID
60687-778_43551356-5d60-0b13-e063-6394a90a6cd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mexiletine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA216463
Marketing category
ANDA
Marketing start
2024-02-23
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
60687-778-11Mexiletine hydrochloride1 in 1 BLISTER PACKCAPSULE13
60687-778-21Mexiletine hydrochloride30 in 1 CARTONCAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-778-11EA - Each60687-77876d4b0b1-31a1-467c-867f-b584eb9caf5f12024-02-14
60687-778-21EA - Each60687-7788461cce0-db7c-46c1-9501-26077a299b0012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-778MEXILETINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20240228_9d0b5d78-63dc-4208-b590-0789d3ed5785.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362706mexiletine HCl 150 MG Oral CapsulePSN9d0b5d78-63dc-4208-b590-0789d3ed57853
1362706mexiletine hydrochloride 150 MG Oral CapsuleSCD9d0b5d78-63dc-4208-b590-0789d3ed57853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-778-11606870778111 in 1 BLISTER PACKHistorical
60687-778-216068707782130 BLISTER PACK in 1 CARTON (60687-778-21) / 1 CAPSULE in 1 BLISTER PACK (60687-778-11) 30 blister pack2024-02-23NoNoHistorical