FDA.reportPublic FDA data

Ranolazine

Product NDC
70771-1499
11-digit product format
707711499
Labeler code
70771
Product ID
70771-1499_b80bd37e-952a-4a30-9b48-6dca616f181d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210188
Marketing category
ANDA
Marketing start
2019-09-10
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
70771-1499-1Ranolazine100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
70771-1499-2Ranolazine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
70771-1499-4Ranolazine10 in 1 CARTONTABLET, EXTENDED RELEASE104
70771-1499-5Ranolazine500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
70771-1499-6Ranolazine60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1499RANOLAZINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 5 package rows20231014_d74f3dea-7357-4e9a-be9a-2f498a44108a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNd74f3dea-7357-4e9a-be9a-2f498a44108a4
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNd74f3dea-7357-4e9a-be9a-2f498a44108a4
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDd74f3dea-7357-4e9a-be9a-2f498a44108a4
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDd74f3dea-7357-4e9a-be9a-2f498a44108a4
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYd74f3dea-7357-4e9a-be9a-2f498a44108a4
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYd74f3dea-7357-4e9a-be9a-2f498a44108a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1499-170771149901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1499-1) 2019-09-100000-00-00NoNoCurrent
70771-1499-27077114990210 in 1 BLISTER PACKHistorical
70771-1499-47077114990410 BLISTER PACK in 1 CARTON (70771-1499-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1499-2) 10 blister pack2019-09-100000-00-00NoNoCurrent
70771-1499-570771149905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1499-5) 2019-09-100000-00-00NoNoCurrent
70771-1499-67077114990660 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1499-6) 2019-09-100000-00-00NoNoCurrent