FDA.reportPublic FDA data

Ranolazine

Product NDC
63304-018
11-digit product format
633040018
Labeler code
63304
Product ID
63304-018_9d320810-99dc-4276-ab06-688b60cc957d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211707
Marketing category
ANDA
Marketing start
2019-05-28
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
63304-018-05Ranolazine500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
63304-018-28Ranolazine180 in 1 BOTTLETABLET, EXTENDED RELEASE1804
63304-018-60Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-018-60EA - Each63304-018e8c226ec-a03d-443a-abdd-8dfbd4db2fe112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-018RANOLAZINE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 3 package rows20200818_c5848232-b7fd-4fe5-a543-16d6c4b5c0b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNc5848232-b7fd-4fe5-a543-16d6c4b5c0b14
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNc5848232-b7fd-4fe5-a543-16d6c4b5c0b14
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDc5848232-b7fd-4fe5-a543-16d6c4b5c0b14
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDc5848232-b7fd-4fe5-a543-16d6c4b5c0b14
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYc5848232-b7fd-4fe5-a543-16d6c4b5c0b14
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYc5848232-b7fd-4fe5-a543-16d6c4b5c0b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-018-0563304001805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-05) 2019-05-280000-00-00NoNoCurrent
63304-018-2863304001828180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-28) 2019-05-280000-00-00NoNoCurrent
63304-018-606330400186060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-60) 2019-05-280000-00-00NoNoCurrent