FDA.reportPublic FDA data

Ranolazine

Product NDC
69367-293
11-digit product format
693670293
Labeler code
69367
Product ID
69367-293_38a38464-5bd7-40e4-82fc-2fc5fe42cef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA211829
Marketing category
ANDA
Marketing start
2021-08-24
Substance
RANOLAZINE
Active strength
500 mg/1
Pharmacologic classes
Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranolazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANOLAZINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA6IEZ5M406
Rxcui616749, 728231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-293-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-293RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 1 package rows20210903_b91e88a0-04d0-4d0d-92d8-966b27a48e29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN989e1688-a0b5-4297-bf91-234de2a0b4452
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN989e1688-a0b5-4297-bf91-234de2a0b4452
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD989e1688-a0b5-4297-bf91-234de2a0b4452
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD989e1688-a0b5-4297-bf91-234de2a0b4452
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY989e1688-a0b5-4297-bf91-234de2a0b4452
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY989e1688-a0b5-4297-bf91-234de2a0b4452
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNb91e88a0-04d0-4d0d-92d8-966b27a48e291
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNb91e88a0-04d0-4d0d-92d8-966b27a48e291
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNc7ed8234-e6bd-4f19-a1ce-40f272a790361
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDb91e88a0-04d0-4d0d-92d8-966b27a48e291
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDb91e88a0-04d0-4d0d-92d8-966b27a48e291
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDc7ed8234-e6bd-4f19-a1ce-40f272a790361
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYb91e88a0-04d0-4d0d-92d8-966b27a48e291
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYb91e88a0-04d0-4d0d-92d8-966b27a48e291
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYc7ed8234-e6bd-4f19-a1ce-40f272a790361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-293-606936702936060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69367-293-60) 2021-08-240000-00-00NoNoCurrent