acebutolol hydrochloride

Generic: acebutolol hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acebutolol hydrochloride
Generic Name acebutolol hydrochloride
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acebutolol hydrochloride 200 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-010
Product ID 42291-010_48481cfc-a410-bc0a-e063-6294a90a7baf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075047
Listing Expiration 2027-12-31
Marketing Start 2023-04-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291010
Hyphenated Format 42291-010

Supplemental Identifiers

RxCUI
998689
UNII
B025Y34C54

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
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42291-010-01)
source: ndc

Packages (1)

42291-010-01 100 CAPSULE in 1 BOTTLE (42291-010-01)

Ingredients (1)

acebutolol hydrochloride (200 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": "48481cfc-a410-bc0a-e063-6294a90a7baf", "openfda": {"unii": ["B025Y34C54"], "rxcui": ["998689"], "spl_set_id": ["fa40a564-a579-15c1-e053-6294a90ad8e9"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42291-010-01)", "package_ndc": "42291-010-01", "marketing_start_date": "20230426"}], "brand_name": "Acebutolol Hydrochloride", "product_id": "42291-010_48481cfc-a410-bc0a-e063-6294a90a7baf", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42291-010", "generic_name": "Acebutolol Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acebutolol Hydrochloride", "active_ingredients": [{"name": "ACEBUTOLOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA075047", "marketing_category": "ANDA", "marketing_start_date": "20230426", "listing_expiration_date": "20271231"}