nebivolol

Generic: nebivolol

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebivolol
Generic Name nebivolol
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-391
Product ID 67877-391_4f315a54-2598-4463-8884-0b643e86f8c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203828
Listing Expiration 2026-12-31
Marketing Start 2021-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877391
Hyphenated Format 67877-391

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0367877393308 0367877391304 0367877392905 0367877390901
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 ANDA203828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-391-01)
  • 30 TABLET in 1 BOTTLE (67877-391-30)
  • 1 BLISTER PACK in 1 CARTON (67877-391-33) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (67877-391-90)
source: ndc

Packages (4)

67877-391-01 100 TABLET in 1 BOTTLE (67877-391-01) 67877-391-30 30 TABLET in 1 BOTTLE (67877-391-30) 67877-391-33 1 BLISTER PACK in 1 CARTON (67877-391-33) / 10 TABLET in 1 BLISTER PACK 67877-391-90 90 TABLET in 1 BOTTLE (67877-391-90)

Ingredients (1)

nebivolol hydrochloride (10 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": "4f315a54-2598-4463-8884-0b643e86f8c0", "openfda": {"upc": ["0367877393308", "0367877391304", "0367877392905", "0367877390901"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["fecef8fc-b66b-4133-b66f-8d6b72750622"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-391-01)", "package_ndc": "67877-391-01", "marketing_start_date": "20210916"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-391-30)", "package_ndc": "67877-391-30", "marketing_start_date": "20210916"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-391-33)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-391-33", "marketing_start_date": "20210916"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-391-90)", "package_ndc": "67877-391-90", "marketing_start_date": "20210916"}], "brand_name": "Nebivolol", "product_id": "67877-391_4f315a54-2598-4463-8884-0b643e86f8c0", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "67877-391", "generic_name": "Nebivolol", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203828", "marketing_category": "ANDA", "marketing_start_date": "20210916", "listing_expiration_date": "20261231"}