betaxolol

Generic: betaxolol

Labeler: epic pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name betaxolol
Generic Name betaxolol
Labeler epic pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

betaxolol hydrochloride 10 mg/1

Manufacturer
Epic Pharma LLC

Identifiers & Regulatory

Product NDC 42806-038
Product ID 42806-038_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075541
Listing Expiration 2026-12-31
Marketing Start 2010-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806038
Hyphenated Format 42806-038

Supplemental Identifiers

RxCUI
1297753 1297757
UNII
6X97D2XT0O

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 betaxolol (source: ndc)
Generic Name betaxolol (source: ndc)
Application Number ANDA075541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10)
source: ndc

Packages (2)

42806-038-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01) 42806-038-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10)

Ingredients (1)

betaxolol hydrochloride (10 mg/1)

Linked Drug Pages (1)

Betaxolol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "666cb1d9-ec1f-453a-be4f-fafa2b67c1fd", "openfda": {"unii": ["6X97D2XT0O"], "rxcui": ["1297753", "1297757"], "spl_set_id": ["bf716efe-0a9f-43b1-9d8a-c69330b82e18"], "manufacturer_name": ["Epic Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-038-01)", "package_ndc": "42806-038-01", "marketing_start_date": "20100720"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-038-10)", "package_ndc": "42806-038-10", "marketing_start_date": "20100720"}], "brand_name": "Betaxolol", "product_id": "42806-038_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42806-038", "generic_name": "Betaxolol", "labeler_name": "Epic Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betaxolol", "active_ingredients": [{"name": "BETAXOLOL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA075541", "marketing_category": "ANDA", "marketing_start_date": "20100720", "listing_expiration_date": "20261231"}