FDA.reportPublic FDA data

ivabradine

Product NDC
69452-191
11-digit product format
694520191
Labeler code
69452
Product ID
69452-191_2eacec81-3528-a573-e063-6394a90a6da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivabradine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA213276
Marketing category
ANDA
Marketing start
2025-03-01
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
69452-191-17ivabradine60 in 1 BOTTLETABLET, FILM COATED601
69452-191-30ivabradine500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-191-17EA - Each69452-19104965fa5-2e4a-42f1-9043-eccbae9ddc0e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-191IVABRADINE TABLET, FILM COATED [BIONPHARMA INC.]1Current NDC, 2 package rows20250302_2ead1cf3-e61a-49c4-e063-6294a90a330f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSN2ead1cf3-e61a-49c4-e063-6294a90a330f1
1649493ivabradine 7.5 MG Oral TabletPSN2ead1cf3-e61a-49c4-e063-6294a90a330f1
1649485ivabradine 5 MG Oral TabletSCD2ead1cf3-e61a-49c4-e063-6294a90a330f1
1649493ivabradine 7.5 MG Oral TabletSCD2ead1cf3-e61a-49c4-e063-6294a90a330f1
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY2ead1cf3-e61a-49c4-e063-6294a90a330f1
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY2ead1cf3-e61a-49c4-e063-6294a90a330f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-191-176945201911760 TABLET, FILM COATED in 1 BOTTLE (69452-191-17) 2025-03-01NoNoCurrent
69452-191-3069452019130500 TABLET, FILM COATED in 1 BOTTLE (69452-191-30) 2025-03-01NoNoCurrent