FDA.reportPublic FDA data

Ranolazine

Product NDC
50268-723
11-digit product format
502680723
Labeler code
50268
Product ID
50268-723_47fc05ed-b529-4ae7-e063-6394a90ae1dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA209953
Marketing category
ANDA
Marketing start
2022-09-20
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
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-723-11Ranolazine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
50268-723-13Ranolazine30 in 1 BOXTABLET, FILM COATED, EXTENDED RE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-723-11EA - Each50268-7230dbd0240-19ad-40fe-9726-2d19c5e5047512022-10-06
50268-723-13EA - Each50268-7231a1aa596-34a7-4193-a100-5883d4c2f89a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-723RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [AVPAK]1Current NDC, Legacy NDC, 2 package rows20220922_e92350e8-5b0b-95d3-e053-2995a90a959b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNe92350e8-5b0b-95d3-e053-2995a90a959b2
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNe92350e8-5b0b-95d3-e053-2995a90a959b2
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDe92350e8-5b0b-95d3-e053-2995a90a959b2
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDe92350e8-5b0b-95d3-e053-2995a90a959b2
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYe92350e8-5b0b-95d3-e053-2995a90a959b2
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYe92350e8-5b0b-95d3-e053-2995a90a959b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-723-11502680723111 in 1 BLISTER PACKHistorical
50268-723-135026807231330 BLISTER PACK in 1 BOX (50268-723-13) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-723-11) 30 blister pack2022-09-200000-00-00NoNoCurrent