FDA.reportPublic FDA data

Ranolazine

Product NDC
0904-7506
11-digit product format
009047506
Labeler code
0904
Product ID
0904-7506_655f85d1-ebab-4b44-8619-2a54b34724a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209953
Marketing category
ANDA
Marketing start
2025-01-17
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
2026-12-31
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

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
0904-7506-04Ranolazine30 in 1 CARTONTABLET, FILM COATED, EXTENDED RE302
0904-7506-04Ranolazine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7506-04EA - Each0904-7506b0f452e7-145f-4bbc-a325-2223c5492e7c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7506RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20250119_6166c40c-4fbe-47c4-92e4-2dc5d3567a86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN6166c40c-4fbe-47c4-92e4-2dc5d3567a862
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD6166c40c-4fbe-47c4-92e4-2dc5d3567a862
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY6166c40c-4fbe-47c4-92e4-2dc5d3567a862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7506-040090475060430 BLISTER PACK in 1 CARTON (0904-7506-04) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2025-01-17NoNoCurrent