FDA.reportPublic FDA data

Ranexa

Product NDC
68151-5004
11-digit product format
681515004
Labeler code
68151
Product ID
68151-5004_892444ae-b9ca-4022-bcd3-f676848f83e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021526
Marketing category
NDA
Marketing start
2006-01-27
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-5004-12020-01-31C16284748780-19d75b9d0-cfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RANEXA safely and effectively. See full prescribing information for RANEXA. RANEXA ® (ranolazine) extended-release tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5004-1Ranexa1 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANOLAZINEACTIVE INGREDIENTA6IEZ5M406RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
RANOLAZINEACTIVE MOIETYA6IEZ5M406RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1URANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5004RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_e038f963-d78f-460e-a11f-46f224061505.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860738Ranexa 500 MG 12HR Extended Release Oral TabletPSNe038f963-d78f-460e-a11f-46f2240615053
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNe038f963-d78f-460e-a11f-46f2240615053
86073812 HR ranolazine 500 MG Extended Release Oral Tablet [Ranexa]SBDe038f963-d78f-460e-a11f-46f2240615053
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDe038f963-d78f-460e-a11f-46f2240615053
860738Ranexa 500 MG 12 HR Extended Release Oral TabletSYe038f963-d78f-460e-a11f-46f2240615053
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYe038f963-d78f-460e-a11f-46f2240615053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5004-1681515004011 in 1 PACKAGEHistorical