nebivolol

Generic: nebivolol

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

Drug Facts

Product Profile

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

nebivolol hydrochloride 2.5 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-353
Product ID 13668-353_a88f1b89-2539-4ca5-b49e-9885611c62a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203966
Listing Expiration 2026-12-31
Marketing Start 2018-03-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668353
Hyphenated Format 13668-353

Supplemental Identifiers

RxCUI
387013 751612 751618 827073
UPC
0313668353303 0313668356304 0313668355307 0313668354300
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 ANDA203966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13668-353-01)
  • 500 TABLET in 1 BOTTLE (13668-353-05)
  • 30 TABLET in 1 BOTTLE (13668-353-30)
  • 90 TABLET in 1 BOTTLE (13668-353-90)
source: ndc

Packages (4)

13668-353-01 100 TABLET in 1 BOTTLE (13668-353-01) 13668-353-05 500 TABLET in 1 BOTTLE (13668-353-05) 13668-353-30 30 TABLET in 1 BOTTLE (13668-353-30) 13668-353-90 90 TABLET in 1 BOTTLE (13668-353-90)

Ingredients (1)

nebivolol hydrochloride (2.5 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": "a88f1b89-2539-4ca5-b49e-9885611c62a3", "openfda": {"upc": ["0313668353303", "0313668356304", "0313668355307", "0313668354300"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751618", "827073"], "spl_set_id": ["3e3dc363-731f-4115-b685-a17620dd2034"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13668-353-01)", "package_ndc": "13668-353-01", "marketing_start_date": "20180302"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-353-05)", "package_ndc": "13668-353-05", "marketing_start_date": "20180302"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13668-353-30)", "package_ndc": "13668-353-30", "marketing_start_date": "20180302"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (13668-353-90)", "package_ndc": "13668-353-90", "marketing_start_date": "20210617"}], "brand_name": "nebivolol", "product_id": "13668-353_a88f1b89-2539-4ca5-b49e-9885611c62a3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "13668-353", "generic_name": "nebivolol", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA203966", "marketing_category": "ANDA", "marketing_start_date": "20180302", "listing_expiration_date": "20261231"}