FDA.reportPublic FDA data

Ranolazine

Product NDC
70756-704
11-digit product format
707560704
Labeler code
70756
Product ID
70756-704_124ce9a6-ff1b-475f-8feb-b31082a51d3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA212284
Marketing category
ANDA
Marketing start
2020-04-01
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
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-704-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-704RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [LIFESTAR PHARMA LLC]5Current NDC, Legacy NDC, 1 package rows20211225_195c4b51-fec2-410d-8d90-487c536a8728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN195c4b51-fec2-410d-8d90-487c536a87287
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN195c4b51-fec2-410d-8d90-487c536a87287
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD195c4b51-fec2-410d-8d90-487c536a87287
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD195c4b51-fec2-410d-8d90-487c536a87287
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY195c4b51-fec2-410d-8d90-487c536a87287
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY195c4b51-fec2-410d-8d90-487c536a87287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-704-607075607046060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70756-704-60) 2020-04-010000-00-00NoNoCurrent