FDA.reportPublic FDA data

RANOLAZINE

Product NDC
73141-021
11-digit product format
731410021
Labeler code
73141
Product ID
73141-021_32becc54-372f-b7eb-e063-6294a90a48b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals
Application
ANDA213517
Marketing category
ANDA
Marketing start
2025-04-08
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
73141-021-02RANOLAZINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-021RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [A2A INTEGRATED PHARMACEUTICALS]1Current NDC, 1 package rows20250416_9fb62878-c76a-4be2-99be-962ce2956af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN9fb62878-c76a-4be2-99be-962ce2956af21
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN9fb62878-c76a-4be2-99be-962ce2956af21
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD9fb62878-c76a-4be2-99be-962ce2956af21
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD9fb62878-c76a-4be2-99be-962ce2956af21
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY9fb62878-c76a-4be2-99be-962ce2956af21
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY9fb62878-c76a-4be2-99be-962ce2956af21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73141-021-027314100210260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73141-021-02) 2025-04-08NoNoCurrent