Home NDC 72603-934 Ivabradine
Product NDC 72603-934
11-digit product format 726030934
Labeler code 72603
Product ID 72603-934_a7fb4728-1c41-4c01-8adb-a22dca0b1b1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivabradine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Northstar Rx 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 2027-12-31
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 A213483-001 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-04-28 A213483-002 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2025-04-28
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 A213483-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213483-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2025-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213483-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213483-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2025-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213483-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213483-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2025-04-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213483-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2025-04-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213483-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2025-04-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ivabradine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IVABRADINE HYDROCHLORIDE 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 72603-934-01 Ivabradine 60 in 1 BOTTLE TABLET, FILM COATED 60 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 72603-934-01 72603093401 60 TABLET, FILM COATED in 1 BOTTLE (72603-934-01) 2026-07-01 0 Current