ivabradine

Generic: ivabradine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ivabradine
Generic Name ivabradine
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ivabradine hydrochloride 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-862
Product ID 60687-862_38e0b27f-e2e8-d69e-e063-6394a90a21dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213366
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 60687862
Hyphenated Format 60687-862

Supplemental Identifiers

RxCUI
1649485
UNII
TP19837BZK

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 ANDA213366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-862-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-862-11)
source: ndc

Packages (1)

60687-862-21 30 BLISTER PACK in 1 CARTON (60687-862-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-862-11)

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": "38e0b27f-e2e8-d69e-e063-6394a90a21dd", "openfda": {"unii": ["TP19837BZK"], "rxcui": ["1649485"], "spl_set_id": ["e881a1ac-9221-4682-939f-966679cfe286"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-862-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-862-11)", "package_ndc": "60687-862-21", "marketing_start_date": "20250701"}], "brand_name": "Ivabradine", "product_id": "60687-862_38e0b27f-e2e8-d69e-e063-6394a90a21dd", "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": "60687-862", "generic_name": "Ivabradine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213366", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}