nebivolol

Generic: nebivolol

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

Drug Facts

Product Profile

Brand Name nebivolol
Generic Name nebivolol
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-458
Product ID 33342-458_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212661
Listing Expiration 2026-12-31
Marketing Start 2019-01-19

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342458
Hyphenated Format 33342-458

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0333342458070 0333342459077 0333342460073 0333342457073
UNII
JGS34J7L9I

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 ANDA212661 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-458-07)
  • 90 TABLET in 1 BOTTLE (33342-458-10)
  • 12 BLISTER PACK in 1 CARTON (33342-458-25) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

33342-458-07 30 TABLET in 1 BOTTLE (33342-458-07) 33342-458-10 90 TABLET in 1 BOTTLE (33342-458-10) 33342-458-25 12 BLISTER PACK in 1 CARTON (33342-458-25) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

nebivolol hydrochloride (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": "b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e", "openfda": {"upc": ["0333342458070", "0333342459077", "0333342460073", "0333342457073"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-458-07)", "package_ndc": "33342-458-07", "marketing_start_date": "20250129"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-458-10)", "package_ndc": "33342-458-10", "marketing_start_date": "20250129"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (33342-458-25)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-458-25", "marketing_start_date": "20250129"}], "brand_name": "Nebivolol", "product_id": "33342-458_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "33342-458", "generic_name": "Nebivolol", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA212661", "marketing_category": "ANDA", "marketing_start_date": "20190119", "listing_expiration_date": "20261231"}