Ranolazine

Product NDC
90096-152
11-digit product format
900960152
Labeler code
90096
Product ID
90096-152_e64620da-e2d0-47d8-a75e-22a8b4db1183
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
ANDA213085
Marketing category
ANDA
Marketing start
2025-10-30
Substance
RANOLAZINE
Active strength
1000 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
RANOLAZINE1000 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
90096-152-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN5f4fc8a4-2bd5-4378-8882-e739c951390e4
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN5f4fc8a4-2bd5-4378-8882-e739c951390e4
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD5f4fc8a4-2bd5-4378-8882-e739c951390e4
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD5f4fc8a4-2bd5-4378-8882-e739c951390e4
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY5f4fc8a4-2bd5-4378-8882-e739c951390e4
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY5f4fc8a4-2bd5-4378-8882-e739c951390e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
90096-152-609009601526060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (90096-152-60) 2026-04-22NoNoCurrent