FDA.reportPublic FDA data

Ranolazine

Product NDC
72578-064
11-digit product format
725780064
Labeler code
72578
Product ID
72578-064_ca6a476b-e330-4618-8661-08ac1125fc3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA210188
Marketing category
ANDA
Marketing start
2019-09-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranolazine
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-064-01Ranolazine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
72578-064-05Ranolazine500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
72578-064-14Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE605
72578-064-30Ranolazine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE105
72578-064-77Ranolazine10 in 1 CARTONTABLET, EXTENDED RELEASE105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-064-14EA - Each72578-0645f1d2ffd-ac81-49b1-ba5f-cd782cc1626b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-064RANOLAZINE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 5 package rows20231021_00979fb3-d70f-493d-94ca-2914cbadaa9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN00979fb3-d70f-493d-94ca-2914cbadaa9d5
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN00979fb3-d70f-493d-94ca-2914cbadaa9d5
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD00979fb3-d70f-493d-94ca-2914cbadaa9d5
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD00979fb3-d70f-493d-94ca-2914cbadaa9d5
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY00979fb3-d70f-493d-94ca-2914cbadaa9d5
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY00979fb3-d70f-493d-94ca-2914cbadaa9d5
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN2373687b-b9a4-496e-b89f-9754f8513fd31
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN2e678c80-1410-433b-8c48-4b210eceb0de1
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD2373687b-b9a4-496e-b89f-9754f8513fd31
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD2e678c80-1410-433b-8c48-4b210eceb0de1
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY2373687b-b9a4-496e-b89f-9754f8513fd31
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY2e678c80-1410-433b-8c48-4b210eceb0de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-064-0172578006401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-01) 2019-09-100000-00-00NoNoCurrent
72578-064-0572578006405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-05) 2019-09-100000-00-00NoNoCurrent
72578-064-147257800641460 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-14) 2019-09-100000-00-00NoNoCurrent
72578-064-307257800643010 in 1 BLISTER PACKHistorical
72578-064-777257800647710 BLISTER PACK in 1 CARTON (72578-064-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-064-30) 10 blister pack2019-09-100000-00-00NoNoCurrent