FDA.reportPublic FDA data

Ranexa

Product NDC
61958-1003
11-digit product format
619581003
Labeler code
61958
Product ID
61958-1003_ba1f4469-5e3c-447a-9d28-8e57a2c32a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Gilead Sciences, Inc.
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
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-1003-1EA - Each61958-1003e968d4ff-306a-413a-b922-afbcff0830ab12012-07-24

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 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-1003-16195810030160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1003-1) 2006-01-270000-00-00NoNoCurrent
61958-1003-26195810030214 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (61958-1003-2) 2006-01-270000-00-00NoNoCurrent
61958-1003-36195810030314 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (61958-1003-3) 2006-01-270000-00-00NoNoCurrent