nadolol

Generic: nadolol

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

Drug Facts

Product Profile

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

nadolol 80 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-135
Product ID 76385-135_4cddb5b7-a38f-4360-9e37-f67386f05e55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210955
Listing Expiration 2027-12-31
Marketing Start 2019-07-26

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 76385135
Hyphenated Format 76385-135

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 ANDA210955 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76385-135-01)
  • 1000 TABLET in 1 BOTTLE (76385-135-10)
source: ndc

Packages (2)

76385-135-01 100 TABLET in 1 BOTTLE (76385-135-01) 76385-135-10 1000 TABLET in 1 BOTTLE (76385-135-10)

Ingredients (1)

nadolol (80 mg/1)

Linked Drug Pages (1)

Nadolol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4cddb5b7-a38f-4360-9e37-f67386f05e55", "openfda": {"nui": ["N0000000161", "N0000175556"], "unii": ["FEN504330V"], "rxcui": ["198006", "198007", "198008"], "spl_set_id": ["5a8014fb-9b65-4457-bfd5-0ab7e6de330e"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76385-135-01)", "package_ndc": "76385-135-01", "marketing_start_date": "20190726"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76385-135-10)", "package_ndc": "76385-135-10", "marketing_start_date": "20190726"}], "brand_name": "Nadolol", "product_id": "76385-135_4cddb5b7-a38f-4360-9e37-f67386f05e55", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "76385-135", "generic_name": "Nadolol", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nadolol", "active_ingredients": [{"name": "NADOLOL", "strength": "80 mg/1"}], "application_number": "ANDA210955", "marketing_category": "ANDA", "marketing_start_date": "20190726", "listing_expiration_date": "20271231"}