ivabradine

Generic: ivabradine

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivabradine
Generic Name ivabradine
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-190
Product ID 69452-190_2eacec81-3528-a573-e063-6394a90a6da4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213276
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Pharmacologic Class

Classes
hyperpolarization-activated cyclic nucleotide-gated channel antagonists [moa] hyperpolarization-activated cyclic nucleotide-gated channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452190
Hyphenated Format 69452-190

Supplemental Identifiers

RxCUI
1649485 1649493
UNII
TP19837BZK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ivabradine (source: ndc)
Generic Name ivabradine (source: ndc)
Application Number ANDA213276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69452-190-30)
source: ndc

Packages (2)

69452-190-17 60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17) 69452-190-30 500 TABLET, FILM COATED in 1 BOTTLE (69452-190-30)

Ingredients (1)

ivabradine hydrochloride (5 mg/1)

Linked Drug Pages (1)

ivabradine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2eacec81-3528-a573-e063-6394a90a6da4", "openfda": {"unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["2ead1cf3-e61a-49c4-e063-6294a90a330f"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17)", "package_ndc": "69452-190-17", "marketing_start_date": "20250301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69452-190-30)", "package_ndc": "69452-190-30", "marketing_start_date": "20250301"}], "brand_name": "ivabradine", "product_id": "69452-190_2eacec81-3528-a573-e063-6394a90a6da4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]", "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]"], "product_ndc": "69452-190", "generic_name": "ivabradine", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213276", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}