FDA.reportPublic FDA data

Ranolazine

Product NDC
68462-319
11-digit product format
684620319
Labeler code
68462
Product ID
68462-319_891a4c1d-ed0c-4002-87d9-e395df0386d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RANOLAZINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA211082
Marketing category
ANDA
Marketing start
2019-07-05
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
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
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
68462-319-05Ranolazine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5005
68462-319-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-319-60EA - Each68462-319e320eaaa-a1ee-4968-ac76-64d7c65a46e812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-319RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 2 package rows20240104_0cf58732-c242-49b0-8e3f-248778b4458d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN0cf58732-c242-49b0-8e3f-248778b4458d5
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN0cf58732-c242-49b0-8e3f-248778b4458d5
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD0cf58732-c242-49b0-8e3f-248778b4458d5
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD0cf58732-c242-49b0-8e3f-248778b4458d5
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY0cf58732-c242-49b0-8e3f-248778b4458d5
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY0cf58732-c242-49b0-8e3f-248778b4458d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-319-0568462031905500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-05) 2019-07-050000-00-00NoNoCurrent
68462-319-606846203196060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-60) 2019-07-050000-00-00NoNoCurrent