ivabradine

Generic: ivabradine

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

Drug Facts

Product Profile

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

ivabradine hydrochloride 7.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-680
Product ID 46708-680_51ac7345-3188-4382-ab1d-9120d6c88927
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 46708680
Hyphenated Format 46708-680

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 ANDA215238 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (46708-680-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (46708-680-60)
source: ndc

Packages (2)

46708-680-45 180 TABLET, FILM COATED in 1 BOTTLE (46708-680-45) 46708-680-60 60 TABLET, FILM COATED in 1 BOTTLE (46708-680-60)

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": "51ac7345-3188-4382-ab1d-9120d6c88927", "openfda": {"unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["51ac7345-3188-4382-ab1d-9120d6c88927"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (46708-680-45)", "package_ndc": "46708-680-45", "marketing_start_date": "20241220"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (46708-680-60)", "package_ndc": "46708-680-60", "marketing_start_date": "20241220"}], "brand_name": "Ivabradine", "product_id": "46708-680_51ac7345-3188-4382-ab1d-9120d6c88927", "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": "46708-680", "generic_name": "Ivabradine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ivabradine", "active_ingredients": [{"name": "IVABRADINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA215238", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}