FDA.reportPublic FDA data

RANOLAZINE

Product NDC
77771-423
11-digit product format
777710423
Labeler code
77771
Product ID
77771-423_2db3da6f-14f6-4c55-ad22-55e475ad9f09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Radha Pharmaceuticals, Inc
Application
ANDA211829
Marketing category
ANDA
Marketing start
2025-06-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RANOLAZINE
Listing expiration
2027-12-31

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
77771-423-60RANOLAZINE60 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-423-60EA - Each77771-4236eda1673-b447-478c-9c08-665eb5a394b112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN38d2833d-44b8-8d46-e063-6394a90a74d82
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN38d2833d-44b8-8d46-e063-6394a90a74d82
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD38d2833d-44b8-8d46-e063-6394a90a74d82
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD38d2833d-44b8-8d46-e063-6394a90a74d82
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY38d2833d-44b8-8d46-e063-6394a90a74d82
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY38d2833d-44b8-8d46-e063-6394a90a74d82
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN45236b7d-3728-1e13-e063-6394a90ad77f1
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD45236b7d-3728-1e13-e063-6394a90ad77f1
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY45236b7d-3728-1e13-e063-6394a90ad77f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
77771-423-607777104236060 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (77771-423-60) 2025-06-30NoNoHistorical