FDA.reportPublic FDA data

Ranexa

Product NDC
61958-1002
11-digit product format
619581002
Labeler code
61958
Product ID
61958-1002_91f49ac7-d683-4c63-9b79-355c13cc28e4
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
2007-02-12
Marketing end
0000-00-00
Substance
RANOLAZINE
Active strength
1000 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
61958-1002-12020-01-31C16284748780-19d75b9cf-f890-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 Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1002-1Ranexa60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ranolazineACTIVE INGREDIENTA6IEZ5M406RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
ranolazineACTIVE MOIETYA6IEZ5M406RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
hypromellose 2910 (3 cps)INACTIVE INGREDIENT0VUT3PMY82RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
HYPROMELLOSE 2910 (5 CPS)INACTIVE INGREDIENTR75537T0T4RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
hypromellose 2910 (6 cps)INACTIVE INGREDIENT0WZ8WG20P6RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1002RANEXA (RANOLAZINE) TABLET, FILM COATED, EXTENDED RELEASE [GILEAD SCIENCES, INC.]2Legacy NDC, 1 package rows20100429_8d442b8c-97a8-40a9-8603-f9cd0542cedc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860737Ranexa 1000 MG 12HR Extended Release Oral TabletPSN8d442b8c-97a8-40a9-8603-f9cd0542cedc2
860738Ranexa 500 MG 12HR Extended Release Oral TabletPSN8d442b8c-97a8-40a9-8603-f9cd0542cedc2
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN8d442b8c-97a8-40a9-8603-f9cd0542cedc2
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN8d442b8c-97a8-40a9-8603-f9cd0542cedc2
86073712 HR ranolazine 1000 MG Extended Release Oral Tablet [Ranexa]SBD8d442b8c-97a8-40a9-8603-f9cd0542cedc2
86073812 HR ranolazine 500 MG Extended Release Oral Tablet [Ranexa]SBD8d442b8c-97a8-40a9-8603-f9cd0542cedc2
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD8d442b8c-97a8-40a9-8603-f9cd0542cedc2
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD8d442b8c-97a8-40a9-8603-f9cd0542cedc2
860737Ranexa 1000 MG 12 HR Extended Release Oral TabletSY8d442b8c-97a8-40a9-8603-f9cd0542cedc2
860738Ranexa 500 MG 12 HR Extended Release Oral TabletSY8d442b8c-97a8-40a9-8603-f9cd0542cedc2
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY8d442b8c-97a8-40a9-8603-f9cd0542cedc2
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY8d442b8c-97a8-40a9-8603-f9cd0542cedc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61958-1002-16195810020160 in 1 BOTTLE, PLASTICHistorical