ivabradine

Generic: ivabradine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivabradine
Generic Name ivabradine
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 7.5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1472
Product ID 70710-1472_cbea8583-e207-402a-b79a-83ff14a3fa9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213442
Listing Expiration 2026-12-31
Marketing Start 2024-07-02

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 707101472
Hyphenated Format 70710-1472

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 ANDA213442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (70710-1472-6)
  • 180 TABLET in 1 BOTTLE (70710-1472-8)
source: ndc

Packages (2)

70710-1472-6 60 TABLET in 1 BOTTLE (70710-1472-6) 70710-1472-8 180 TABLET in 1 BOTTLE (70710-1472-8)

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": "cbea8583-e207-402a-b79a-83ff14a3fa9b", "openfda": {"unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["89134202-971b-4413-a9c9-d31a5c29722b"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (70710-1472-6)", "package_ndc": "70710-1472-6", "marketing_start_date": "20240702"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (70710-1472-8)", "package_ndc": "70710-1472-8", "marketing_start_date": "20240702"}], "brand_name": "ivabradine", "product_id": "70710-1472_cbea8583-e207-402a-b79a-83ff14a3fa9b", "dosage_form": "TABLET", "pharm_class": ["Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]", "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]"], "product_ndc": "70710-1472", "generic_name": "ivabradine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA213442", "marketing_category": "ANDA", "marketing_start_date": "20240702", "listing_expiration_date": "20261231"}