nebivolol

Generic: nebivolol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebivolol
Generic Name nebivolol
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-120
Product ID 82804-120_c6606db5-3937-4e90-9870-3cbfa4ec909e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203825
Listing Expiration 2026-12-31
Marketing Start 2021-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804120
Hyphenated Format 82804-120

Supplemental Identifiers

RxCUI
387013
UPC
0382804120901
UNII
JGS34J7L9I

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 ANDA203825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (82804-120-90)
source: ndc

Packages (1)

82804-120-90 90 TABLET in 1 BOTTLE (82804-120-90)

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": "c6606db5-3937-4e90-9870-3cbfa4ec909e", "openfda": {"upc": ["0382804120901"], "unii": ["JGS34J7L9I"], "rxcui": ["387013"], "spl_set_id": ["c6606db5-3937-4e90-9870-3cbfa4ec909e"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-120-90)", "package_ndc": "82804-120-90", "marketing_start_date": "20240708"}], "brand_name": "Nebivolol", "product_id": "82804-120_c6606db5-3937-4e90-9870-3cbfa4ec909e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82804-120", "generic_name": "Nebivolol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203825", "marketing_category": "ANDA", "marketing_start_date": "20210917", "listing_expiration_date": "20261231"}