ivabradine

Generic: ivabradine

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

Drug Facts

Product Profile

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

ivabradine hydrochloride 5 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-679
Product ID 62332-679_7532e07e-8646-4fdc-aed2-f72e01e8947f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215238
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

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 62332679
Hyphenated Format 62332-679

Supplemental Identifiers

RxCUI
1649485 1649493
UPC
0362332680603 0362332679607
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 ANDA215238 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (62332-679-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (62332-679-60)
source: ndc

Packages (2)

62332-679-45 180 TABLET, FILM COATED in 1 BOTTLE (62332-679-45) 62332-679-60 60 TABLET, FILM COATED in 1 BOTTLE (62332-679-60)

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": "7532e07e-8646-4fdc-aed2-f72e01e8947f", "openfda": {"upc": ["0362332680603", "0362332679607"], "unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["53f15531-796d-442b-a73c-05f048218531"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (62332-679-45)", "package_ndc": "62332-679-45", "marketing_start_date": "20241220"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62332-679-60)", "package_ndc": "62332-679-60", "marketing_start_date": "20241220"}], "brand_name": "Ivabradine", "product_id": "62332-679_7532e07e-8646-4fdc-aed2-f72e01e8947f", "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": "62332-679", "generic_name": "Ivabradine", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA215238", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}