FDA.reportPublic FDA data

Ranolazine

Product NDC
42571-325
11-digit product format
425710325
Labeler code
42571
Product ID
42571-325_d172a3c8-ae0a-9ccb-e053-2a95a90a069e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA211745
Marketing category
ANDA
Marketing start
2020-06-01
Substance
RANOLAZINE
Active strength
1000 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
RANOLAZINE1000 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
42571-325-11Ranolazine100 in 1 CARTONTABLET, EXTENDED RELEASE1004
42571-325-32Ranolazine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
42571-325-60Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE604
42571-325-64Ranolazine180 in 1 BOTTLETABLET, EXTENDED RELEASE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-325-60EA - Each42571-32589850b17-7ea6-46ca-8b7d-bc2f11b668be12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-325RANOLAZINE TABLET, EXTENDED RELEASE [MICRO LABS LIMITED]4Current NDC, Legacy NDC, 4 package rows20211124_f6facddc-c020-436e-8e68-bf9a4223e7cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNf6facddc-c020-436e-8e68-bf9a4223e7cf4
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNf6facddc-c020-436e-8e68-bf9a4223e7cf4
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDf6facddc-c020-436e-8e68-bf9a4223e7cf4
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDf6facddc-c020-436e-8e68-bf9a4223e7cf4
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYf6facddc-c020-436e-8e68-bf9a4223e7cf4
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYf6facddc-c020-436e-8e68-bf9a4223e7cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-325-1142571032511100 BLISTER PACK in 1 CARTON (42571-325-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-325-32) 100 blister pack2020-06-010000-00-00NoNoCurrent
42571-325-324257103253210 in 1 BLISTER PACKHistorical
42571-325-604257103256060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-325-60) 2020-06-010000-00-00NoNoCurrent
42571-325-6442571032564180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-325-64) 2020-06-010000-00-00NoNoCurrent