FDA.reportPublic FDA data

Ranolazine

Product NDC
27241-125
11-digit product format
272410125
Labeler code
27241
Product ID
27241-125_933f695e-e4f4-4c75-80fc-aea9a30aa13d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA210054
Marketing category
ANDA
Marketing start
2019-08-23
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
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-125-02Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE608
27241-125-05Ranolazine500 in 1 BOTTLETABLET, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-125-02EA - Each27241-1254e435026-9dae-4d6c-b94e-af8d559e044512019-06-19
27241-125-05EA - Each27241-125d187f26d-00b0-45d9-be62-e43bec03a77e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-125RANOLAZINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]7Current NDC, Legacy NDC, 2 package rows20211126_8bfd1a61-547a-4847-ae4e-480b17da6272.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN8bfd1a61-547a-4847-ae4e-480b17da62728
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN8bfd1a61-547a-4847-ae4e-480b17da62728
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD8bfd1a61-547a-4847-ae4e-480b17da62728
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD8bfd1a61-547a-4847-ae4e-480b17da62728
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY8bfd1a61-547a-4847-ae4e-480b17da62728
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY8bfd1a61-547a-4847-ae4e-480b17da62728
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-125-022724101250260 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-125-02) 2019-08-230000-00-00NoNoCurrent
27241-125-0527241012505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-125-05) 2021-07-140000-00-00NoNoCurrent