ivabradine

Generic: ivabradine

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

Drug Facts

Product Profile

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

ivabradine hydrochloride 5 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-336
Product ID 72205-336_676907d3-b374-4baa-8422-c04706409540
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213483
Listing Expiration 2026-12-31
Marketing Start 2025-04-28

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 72205336
Hyphenated Format 72205-336

Supplemental Identifiers

RxCUI
1649485 1649493
UPC
0372205337183 0372205337602 0372205336186 0372205336605
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 ANDA213483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72205-336-60)
source: ndc

Packages (2)

72205-336-18 180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18) 72205-336-60 60 TABLET, FILM COATED in 1 BOTTLE (72205-336-60)

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": "676907d3-b374-4baa-8422-c04706409540", "openfda": {"upc": ["0372205337183", "0372205337602", "0372205336186", "0372205336605"], "unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["676907d3-b374-4baa-8422-c04706409540"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72205-336-18)", "package_ndc": "72205-336-18", "marketing_start_date": "20250701"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72205-336-60)", "package_ndc": "72205-336-60", "marketing_start_date": "20250701"}], "brand_name": "Ivabradine", "product_id": "72205-336_676907d3-b374-4baa-8422-c04706409540", "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": "72205-336", "generic_name": "Ivabradine", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213483", "marketing_category": "ANDA", "marketing_start_date": "20250428", "listing_expiration_date": "20261231"}