acebutolol hydrochloride

Generic: acebutolol hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acebutolol hydrochloride
Generic Name acebutolol hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acebutolol hydrochloride 400 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-670
Product ID 53746-670_32106d1d-d15a-41e6-9e2a-57394e8ae558
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075047
Listing Expiration 2026-12-31
Marketing Start 2009-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746670
Hyphenated Format 53746-670

Supplemental Identifiers

RxCUI
998685 998689
UPC
0353746670014 0353746669018
UNII
B025Y34C54

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 acebutolol hydrochloride (source: ndc)
Generic Name acebutolol hydrochloride (source: ndc)
Application Number ANDA075047 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (53746-670-01)
  • 500 CAPSULE in 1 BOTTLE (53746-670-05)
  • 30 CAPSULE in 1 BOTTLE (53746-670-30)
source: ndc

Packages (3)

53746-670-01 100 CAPSULE in 1 BOTTLE (53746-670-01) 53746-670-05 500 CAPSULE in 1 BOTTLE (53746-670-05) 53746-670-30 30 CAPSULE in 1 BOTTLE (53746-670-30)

Ingredients (1)

acebutolol hydrochloride (400 mg/1)

Linked Drug Pages (1)

Acebutolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32106d1d-d15a-41e6-9e2a-57394e8ae558", "openfda": {"upc": ["0353746670014", "0353746669018"], "unii": ["B025Y34C54"], "rxcui": ["998685", "998689"], "spl_set_id": ["fe2cd5c0-ee16-4bcb-ad92-3755881dbe79"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (53746-670-01)", "package_ndc": "53746-670-01", "marketing_start_date": "20091201"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (53746-670-05)", "package_ndc": "53746-670-05", "marketing_start_date": "20091201"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (53746-670-30)", "package_ndc": "53746-670-30", "marketing_start_date": "20091201"}], "brand_name": "Acebutolol Hydrochloride", "product_id": "53746-670_32106d1d-d15a-41e6-9e2a-57394e8ae558", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "53746-670", "generic_name": "Acebutolol Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acebutolol Hydrochloride", "active_ingredients": [{"name": "ACEBUTOLOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA075047", "marketing_category": "ANDA", "marketing_start_date": "20091201", "listing_expiration_date": "20261231"}