FDA.reportPublic FDA data

Ranolazine

Product NDC
59651-009
11-digit product format
596510009
Labeler code
59651
Product ID
59651-009_ee3c2383-a36a-4abe-9764-89f817798f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209081
Marketing category
ANDA
Marketing start
2022-12-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranolazine
Listing expiration
2026-12-31

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
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-009-18Ranolazine180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1802
59651-009-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
59651-009-99Ranolazine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-009-60EA - Each59651-0095ace4ae7-6540-4b59-993d-f5b4eb838fd712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-009RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 3 package rows20240216_49873158-5c0a-41da-86a2-369ef6b0cbc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN49873158-5c0a-41da-86a2-369ef6b0cbc82
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN49873158-5c0a-41da-86a2-369ef6b0cbc82
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD49873158-5c0a-41da-86a2-369ef6b0cbc82
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD49873158-5c0a-41da-86a2-369ef6b0cbc82
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY49873158-5c0a-41da-86a2-369ef6b0cbc82
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY49873158-5c0a-41da-86a2-369ef6b0cbc82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-009-1859651000918180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18) 2022-12-230000-00-00NoNoCurrent
59651-009-605965100096060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60) 2022-12-230000-00-00NoNoCurrent
59651-009-99596510009991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99) 2022-12-230000-00-00NoNoCurrent