FDA.reportPublic FDA data

Ranolazine

Product NDC
60687-549
11-digit product format
606870549
Labeler code
60687
Product ID
60687-549_23955366-9210-f95f-e063-6394a90a7e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210054
Marketing category
ANDA
Marketing start
2020-08-19
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
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-549-11Ranolazine1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
60687-549-21Ranolazine30 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-549-11EA - Each60687-54942329196-9970-4dfb-88d1-e7b0bcfdb1c112020-09-14
60687-549-21EA - Each60687-549f785ddec-2864-4c91-8c69-397c304fc5d012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-549RANOLAZINE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20241004_90c5a0c2-542c-467e-9c0c-ef320534c560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN90c5a0c2-542c-467e-9c0c-ef320534c5603
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD90c5a0c2-542c-467e-9c0c-ef320534c5603
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY90c5a0c2-542c-467e-9c0c-ef320534c5603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-549-11606870549111 in 1 BLISTER PACKHistorical
60687-549-216068705492130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11) 30 blister pack2020-08-190000-00-00NoNoCurrent