Home NDC 46708-679 Ivabradine
Product NDC 46708-679
11-digit product format 467080679
Labeler code 46708
Product ID 46708-679_51ac7345-3188-4382-ab1d-9120d6c88927
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ivabradine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA215238
Marketing category ANDA
Marketing start 2024-12-20
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 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 A215238-001 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 A215238-002 IVABRADINE HYDROCHLORIDE IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08
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 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215238-001 IVABRADINE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2024-11-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215238-002 IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE TABLET / ORAL AB 2024-11-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ivabradine
Listing expiration 2026-12-31 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 46708-679-45 Ivabradine 180 in 1 BOTTLE TABLET, FILM COATED 180 1 46708-679-60 Ivabradine 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-679 IVABRADINE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20241222_51ac7345-3188-4382-ab1d-9120d6c88927.zip
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 Exclude flag Status 46708-679-45 46708067945 180 TABLET, FILM COATED in 1 BOTTLE (46708-679-45) 2024-12-20 No No Current 46708-679-60 46708067960 60 TABLET, FILM COATED in 1 BOTTLE (46708-679-60) 2024-12-20 No No Current