nebivolol hydrochloride

Generic: nebivolol hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebivolol hydrochloride
Generic Name nebivolol hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 20 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-378
Product ID 29300-378_1a80b28a-62f6-443e-8e8d-fc89b74be5ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213830
Listing Expiration 2026-12-31
Marketing Start 2022-04-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300378
Hyphenated Format 29300-378

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0329300375138 0329300376135 0329300377132 0329300378139
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 hydrochloride (source: ndc)
Generic Name nebivolol hydrochloride (source: ndc)
Application Number ANDA213830 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (29300-378-05)
  • 30 TABLET in 1 BOTTLE (29300-378-13)
  • 90 TABLET in 1 BOTTLE (29300-378-19)
source: ndc

Packages (3)

29300-378-05 500 TABLET in 1 BOTTLE (29300-378-05) 29300-378-13 30 TABLET in 1 BOTTLE (29300-378-13) 29300-378-19 90 TABLET in 1 BOTTLE (29300-378-19)

Ingredients (1)

nebivolol hydrochloride (20 mg/1)

Linked Drug Pages (1)

Nebivolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a80b28a-62f6-443e-8e8d-fc89b74be5ea", "openfda": {"upc": ["0329300375138", "0329300376135", "0329300377132", "0329300378139"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["b1762bbb-b5be-48a7-8101-bb736f28845a"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (29300-378-05)", "package_ndc": "29300-378-05", "marketing_start_date": "20220404"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (29300-378-13)", "package_ndc": "29300-378-13", "marketing_start_date": "20220404"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (29300-378-19)", "package_ndc": "29300-378-19", "marketing_start_date": "20220404"}], "brand_name": "Nebivolol Hydrochloride", "product_id": "29300-378_1a80b28a-62f6-443e-8e8d-fc89b74be5ea", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "29300-378", "generic_name": "Nebivolol Hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nebivolol Hydrochloride", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA213830", "marketing_category": "ANDA", "marketing_start_date": "20220404", "listing_expiration_date": "20261231"}