FDA.reportPublic FDA data

Ivabradine

Product NDC
72205-336
11-digit product format
722050336
Labeler code
72205
Product ID
72205-336_676907d3-b374-4baa-8422-c04706409540
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivabradine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213483
Marketing category
ANDA
Marketing start
2025-04-28
Substance
IVABRADINE HYDROCHLORIDE
Active strength
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 HYDROCHLORIDE5 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
72205-336-18Ivabradine180 in 1 BOTTLETABLET, FILM COATED1801
72205-336-60Ivabradine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-336-60EA - Each72205-336f423d51c-fa12-4cc1-9a83-17a21bf8655f12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-336IVABRADINE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250508_676907d3-b374-4baa-8422-c04706409540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN676907d3-b374-4baa-8422-c047064095401
1649493ivabradine 7.5 MG Oral TabletPSN676907d3-b374-4baa-8422-c047064095401
1649485ivabradine 5 MG Oral TabletSCD676907d3-b374-4baa-8422-c047064095401
1649493ivabradine 7.5 MG Oral TabletSCD676907d3-b374-4baa-8422-c047064095401
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY676907d3-b374-4baa-8422-c047064095401
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY676907d3-b374-4baa-8422-c047064095401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-336-1872205033618180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18) 2025-07-01NoNoHistorical
72205-336-607220503366060 TABLET, FILM COATED in 1 BOTTLE (72205-336-60) 2025-07-01NoNoHistorical