FDA.reportPublic FDA data

Ranolazine

Product NDC
42571-324
11-digit product format
425710324
Labeler code
42571
Product ID
42571-324_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
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
42571-324-05Ranolazine500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
42571-324-11Ranolazine100 in 1 CARTONTABLET, EXTENDED RELEASE1004
42571-324-32Ranolazine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
42571-324-60Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE604
42571-324-64Ranolazine180 in 1 BOTTLETABLET, EXTENDED RELEASE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-324-60EA - Each42571-324ff47a96f-bf4a-453e-898b-efa1f255f6f812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-324RANOLAZINE TABLET, EXTENDED RELEASE [MICRO LABS LIMITED]4Current NDC, Legacy NDC, 5 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
42571-324-0542571032405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-05) 2020-06-010000-00-00NoNoCurrent
42571-324-1142571032411100 BLISTER PACK in 1 CARTON (42571-324-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-324-32) 100 blister pack2020-06-010000-00-00NoNoCurrent
42571-324-324257103243210 in 1 BLISTER PACKHistorical
42571-324-604257103246060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-60) 2020-06-010000-00-00NoNoCurrent
42571-324-6442571032464180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-64) 2020-06-010000-00-00NoNoCurrent