nebivolol

Generic: nebivolol hydrochloride

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

Drug Facts

Product Profile

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

nebivolol hydrochloride 5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-616
Product ID 68462-616_151f00ae-13ed-4174-bf4d-bc30f1fb9d69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203821
Listing Expiration 2026-12-31
Marketing Start 2017-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462616
Hyphenated Format 68462-616

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0368462618011 0368462617014 0368462615010 0368462616017
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 hydrochloride (source: ndc)
Application Number ANDA203821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-616-01)
  • 10 BLISTER PACK in 1 CARTON (68462-616-11) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (68462-616-30)
source: ndc

Packages (3)

68462-616-01 100 TABLET in 1 BOTTLE (68462-616-01) 68462-616-11 10 BLISTER PACK in 1 CARTON (68462-616-11) / 10 TABLET in 1 BLISTER PACK 68462-616-30 30 TABLET in 1 BOTTLE (68462-616-30)

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": "151f00ae-13ed-4174-bf4d-bc30f1fb9d69", "openfda": {"upc": ["0368462618011", "0368462617014", "0368462615010", "0368462616017"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["cb47560d-9e35-4b0f-b12b-6ea478684a5b"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-616-01)", "package_ndc": "68462-616-01", "marketing_start_date": "20170525"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-616-11)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68462-616-11", "marketing_start_date": "20170525"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68462-616-30)", "package_ndc": "68462-616-30", "marketing_start_date": "20170525"}], "brand_name": "nebivolol", "product_id": "68462-616_151f00ae-13ed-4174-bf4d-bc30f1fb9d69", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68462-616", "generic_name": "nebivolol hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203821", "marketing_category": "ANDA", "marketing_start_date": "20170525", "listing_expiration_date": "20261231"}