ivabradine

Generic: ivabradine

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivabradine
Generic Name ivabradine
Labeler ingenus pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 7.5 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-363
Product ID 50742-363_6d23c13f-f81d-4bc9-9ded-be94c025e8f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214051
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

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 50742363
Hyphenated Format 50742-363

Supplemental Identifiers

RxCUI
1649485 1649493
UPC
0350742363605 0350742362608
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 ANDA214051 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60)
source: ndc

Packages (1)

50742-363-60 60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60)

Ingredients (1)

ivabradine hydrochloride (7.5 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": "6d23c13f-f81d-4bc9-9ded-be94c025e8f7", "openfda": {"upc": ["0350742363605", "0350742362608"], "unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["2e70f883-8c01-4ac2-815d-4a6d561c711a"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60)", "package_ndc": "50742-363-60", "marketing_start_date": "20240715"}], "brand_name": "IVABRADINE", "product_id": "50742-363_6d23c13f-f81d-4bc9-9ded-be94c025e8f7", "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": "50742-363", "generic_name": "IVABRADINE", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IVABRADINE", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA214051", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}