FDA.reportPublic FDA data

IVABRADINE

Product NDC
50742-363
11-digit product format
507420363
Labeler code
50742
Product ID
50742-363_6d23c13f-f81d-4bc9-9ded-be94c025e8f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IVABRADINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA214051
Marketing category
ANDA
Marketing start
2024-07-15
Substance
IVABRADINE HYDROCHLORIDE
Active strength
7.5 mg/1
Pharmacologic classes
Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IVABRADINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVABRADINE HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTP19837BZK
Rxcui1649485, 1649493

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eebd3ed3-f483-47f1-9e64-83ee4010ac6eProduct name520260130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-363-60IVABRADINE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-363-60EA - Each50742-3633ef41a13-8c7a-4f10-8cfc-0409fb92474c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-363IVABRADINE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250319_2e70f883-8c01-4ac2-815d-4a6d561c711a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN236cc914-7eef-600c-e063-6394a90a4bd12
1649485ivabradine 5 MG Oral TabletPSN2e70f883-8c01-4ac2-815d-4a6d561c711a2
1649493ivabradine 7.5 MG Oral TabletPSN236cc914-7eef-600c-e063-6394a90a4bd12
1649493ivabradine 7.5 MG Oral TabletPSN2e70f883-8c01-4ac2-815d-4a6d561c711a2
1649485ivabradine 5 MG Oral TabletSCD236cc914-7eef-600c-e063-6394a90a4bd12
1649485ivabradine 5 MG Oral TabletSCD2e70f883-8c01-4ac2-815d-4a6d561c711a2
1649493ivabradine 7.5 MG Oral TabletSCD236cc914-7eef-600c-e063-6394a90a4bd12
1649493ivabradine 7.5 MG Oral TabletSCD2e70f883-8c01-4ac2-815d-4a6d561c711a2
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY236cc914-7eef-600c-e063-6394a90a4bd12
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY2e70f883-8c01-4ac2-815d-4a6d561c711a2
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY236cc914-7eef-600c-e063-6394a90a4bd12
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY2e70f883-8c01-4ac2-815d-4a6d561c711a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50742-363-605074203636060 TABLET, FILM COATED in 1 BOTTLE (50742-363-60) 2024-07-15NoNoHistorical