FDA.reportPublic FDA data

Ranolazine

Product NDC
71610-518
11-digit product format
716100518
Labeler code
71610
Product ID
71610-518_1524482d-40bd-a0f9-e063-6394a90a1a37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA212781
Marketing category
ANDA
Marketing start
2020-10-27
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

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
71610-518-42Ranolazine1800 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE18002
71610-518-83Ranolazine3600 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE36002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-518-42EA - Each71610-5189a4bae5a-4e64-4401-8f78-8d86c2aad55e12024-05-16
71610-518-83EA - Each71610-51811eb1fd7-baf7-4539-ac9c-4dfd02fa937212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-518RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20240405_abb32182-46ba-49d2-b2ac-13de2ecf802d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNabb32182-46ba-49d2-b2ac-13de2ecf802d2
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDabb32182-46ba-49d2-b2ac-13de2ecf802d2
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYabb32182-46ba-49d2-b2ac-13de2ecf802d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-518-42716100518421800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-42) 2024-04-01NoNoCurrent
71610-518-83716100518833600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-518-83) 2021-01-220000-00-00NoNoCurrent