nadolol

Generic: nadolol

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

Drug Facts

Product Profile

Brand Name nadolol
Generic Name nadolol
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nadolol 40 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-733
Product ID 68382-733_d91f4594-496e-49f2-a187-ddd86f8634b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207761
Listing Expiration 2026-12-31
Marketing Start 2017-08-08

Pharmacologic Class

Established (EPC)
beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic beta-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382733
Hyphenated Format 68382-733

Supplemental Identifiers

RxCUI
198006 198007 198008
UNII
FEN504330V
NUI
N0000000161 N0000175556

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 nadolol (source: ndc)
Generic Name nadolol (source: ndc)
Application Number ANDA207761 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-733-01)
  • 1000 TABLET in 1 BOTTLE (68382-733-10)
  • 90 TABLET in 1 BOTTLE (68382-733-16)
  • 10 BLISTER PACK in 1 CARTON (68382-733-77) / 1 TABLET in 1 BLISTER PACK (68382-733-30)
source: ndc

Packages (4)

Ingredients (1)

nadolol (40 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d91f4594-496e-49f2-a187-ddd86f8634b4", "openfda": {"nui": ["N0000000161", "N0000175556"], "unii": ["FEN504330V"], "rxcui": ["198006", "198007", "198008"], "spl_set_id": ["a0a38f9b-268d-4463-881d-5bee6cd92e8a"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-733-01)", "package_ndc": "68382-733-01", "marketing_start_date": "20170808"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-733-10)", "package_ndc": "68382-733-10", "marketing_start_date": "20170808"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-733-16)", "package_ndc": "68382-733-16", "marketing_start_date": "20170808"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-733-77)  / 1 TABLET in 1 BLISTER PACK (68382-733-30)", "package_ndc": "68382-733-77", "marketing_start_date": "20170808"}], "brand_name": "Nadolol", "product_id": "68382-733_d91f4594-496e-49f2-a187-ddd86f8634b4", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68382-733", "generic_name": "Nadolol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nadolol", "active_ingredients": [{"name": "NADOLOL", "strength": "40 mg/1"}], "application_number": "ANDA207761", "marketing_category": "ANDA", "marketing_start_date": "20170808", "listing_expiration_date": "20261231"}