FDA.reportPublic FDA data

RANOLAZINE

Product NDC
68180-355
11-digit product format
681800355
Labeler code
68180
Product ID
68180-355_e5f38101-deda-4a41-8c51-76edce7df3e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA201046
Marketing category
ANDA
Marketing start
2019-02-27
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
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
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
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-355-02RANOLAZINE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50011
68180-355-07RANOLAZINE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-355-07EA - Each68180-355b4d21c67-0327-4016-8bf7-938cb2333a6c12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-355RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20231209_595821d7-1fbf-49a5-9c62-d78f27af39b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN595821d7-1fbf-49a5-9c62-d78f27af39b411
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN595821d7-1fbf-49a5-9c62-d78f27af39b411
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD595821d7-1fbf-49a5-9c62-d78f27af39b411
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD595821d7-1fbf-49a5-9c62-d78f27af39b411
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY595821d7-1fbf-49a5-9c62-d78f27af39b411
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY595821d7-1fbf-49a5-9c62-d78f27af39b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-355-0268180035502500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-355-02) 2019-02-270000-00-00NoNoCurrent
68180-355-076818003550760 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-355-07) 2019-02-270000-00-00NoNoCurrent