ivabradine

Generic: ivabradine

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

Drug Facts

Product Profile

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

ivabradine hydrochloride 5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-053
Product ID 31722-053_174dfa8e-391c-3a0d-e063-6294a90af7ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213366
Listing Expiration 2026-12-31
Marketing Start 2022-10-05

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 31722053
Hyphenated Format 31722-053

Supplemental Identifiers

RxCUI
1649485 1649493
UPC
0331722054607 0331722053600
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 ANDA213366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-053-60)
source: ndc

Packages (1)

31722-053-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-053-60)

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": "174dfa8e-391c-3a0d-e063-6294a90af7ca", "openfda": {"upc": ["0331722054607", "0331722053600"], "unii": ["TP19837BZK"], "rxcui": ["1649485", "1649493"], "spl_set_id": ["602d1c55-0e4d-452a-a087-888fdbaa7568"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-053-60)", "package_ndc": "31722-053-60", "marketing_start_date": "20221005"}], "brand_name": "Ivabradine", "product_id": "31722-053_174dfa8e-391c-3a0d-e063-6294a90af7ca", "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": "31722-053", "generic_name": "Ivabradine", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20221005", "listing_expiration_date": "20261231"}