FDA.reportPublic FDA data

RANOLAZINE

Product NDC
71610-322
11-digit product format
716100322
Labeler code
71610
Product ID
71610-322_ebab2e5e-06e9-4d86-a335-cf9d48b2e9ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA211829
Marketing category
ANDA
Marketing start
2019-06-04
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
500 mg/1
Pharmacologic classes
Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-322-832023-01-30C16284748780-1f386c649-ebaf-0266-e053-dadaa90a7c1aRANOLAZINE EXTENDED-RELEASE TABLETS These highlights do not include all the information needed to use RANOLAZINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE extended-release tablets, for oral use. Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-322-83RANOLAZINE3600 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE36001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-322-83EA - Each71610-322fe84f8de-d7cc-413b-a60e-fdb132b59de112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-322RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20190831_c842805c-c78d-474e-8a33-c2e828bad800.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNc842805c-c78d-474e-8a33-c2e828bad8001
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDc842805c-c78d-474e-8a33-c2e828bad8001
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYc842805c-c78d-474e-8a33-c2e828bad8001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-322-83716100322833600 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (71610-322-83) 2019-08-130000-00-00NoNoCurrent