Home NDC 69452-191 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213276-001 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 A213276-002 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213276-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-09-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213276-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-09-05 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ivabradine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVABRADINE HYDROCHLORIDE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TP19837BZK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649485 Internal RxNorm lookup 1649493 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69452-191-17 ivabradine 60 in 1 BOTTLE TABLET, FILM COATED 60 1 69452-191-30 ivabradine 500 in 1 BOTTLE TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-191 IVABRADINE TABLET, FILM COATED [BIONPHARMA INC.] 1 Current NDC, 2 package rows 20250302_2ead1cf3-e61a-49c4-e063-6294a90a330f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-191-17 69452019117 60 TABLET, FILM COATED in 1 BOTTLE (69452-191-17) 2025-03-01 No No Current 69452-191-30 69452019130 500 TABLET, FILM COATED in 1 BOTTLE (69452-191-30) 2025-03-01 No No Current