FDA.reportPublic FDA data

RANOLAZINE

Product NDC
72319-021
11-digit product format
723190021
Labeler code
72319
Product ID
72319-021_163908d8-6b41-4e68-b14c-76faa57c7ac0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA213517
Marketing category
ANDA
Marketing start
2022-06-15
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72319-021-02RANOLAZINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72319-021-02EA - Each72319-021a0500bb1-673c-40ce-b1a1-55208c17136712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-021RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [I3 PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20221019_de3185bf-448a-15f7-e053-2995a90a9a2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNde3185bf-448a-15f7-e053-2995a90a9a2e4
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNde3185bf-448a-15f7-e053-2995a90a9a2e4
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDde3185bf-448a-15f7-e053-2995a90a9a2e4
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDde3185bf-448a-15f7-e053-2995a90a9a2e4
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYde3185bf-448a-15f7-e053-2995a90a9a2e4
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYde3185bf-448a-15f7-e053-2995a90a9a2e4
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN9199e28a-ddbe-46a4-ab26-9b08034289be1
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD9199e28a-ddbe-46a4-ab26-9b08034289be1
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY9199e28a-ddbe-46a4-ab26-9b08034289be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72319-021-027231900210260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72319-021-02) 2022-06-150000-00-00NoNoCurrent