nebivolol

Generic: nebivolol

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebivolol
Generic Name nebivolol
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol 5 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-525
Product ID 43547-525_a3b47cb5-4f9f-4788-945b-0012a54c0884
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212682
Listing Expiration 2026-12-31
Marketing Start 2022-02-14

Pharmacologic Class

Established (EPC)
beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic beta-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547525
Hyphenated Format 43547-525

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0343547526030 0343547527037 0343547525033 0343547524036
UNII
030Y90569U
NUI
N0000000161 N0000175556

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 nebivolol (source: ndc)
Generic Name nebivolol (source: ndc)
Application Number ANDA212682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-525-03)
  • 90 TABLET in 1 BOTTLE (43547-525-09)
  • 500 TABLET in 1 BOTTLE (43547-525-50)
source: ndc

Packages (3)

43547-525-03 30 TABLET in 1 BOTTLE (43547-525-03) 43547-525-09 90 TABLET in 1 BOTTLE (43547-525-09) 43547-525-50 500 TABLET in 1 BOTTLE (43547-525-50)

Ingredients (1)

nebivolol (5 mg/1)

Linked Drug Pages (1)

NEBIVOLOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a3b47cb5-4f9f-4788-945b-0012a54c0884", "openfda": {"nui": ["N0000000161", "N0000175556"], "upc": ["0343547526030", "0343547527037", "0343547525033", "0343547524036"], "unii": ["030Y90569U"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["51d3f12f-94cc-4f58-94d3-61990e16adfc"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-525-03)", "package_ndc": "43547-525-03", "marketing_start_date": "20220214"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-525-09)", "package_ndc": "43547-525-09", "marketing_start_date": "20220214"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-525-50)", "package_ndc": "43547-525-50", "marketing_start_date": "20220214"}], "brand_name": "NEBIVOLOL", "product_id": "43547-525_a3b47cb5-4f9f-4788-945b-0012a54c0884", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "43547-525", "generic_name": "nebivolol", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEBIVOLOL", "active_ingredients": [{"name": "NEBIVOLOL", "strength": "5 mg/1"}], "application_number": "ANDA212682", "marketing_category": "ANDA", "marketing_start_date": "20220214", "listing_expiration_date": "20261231"}