acebutolol hydrochloride

Generic: acebutolol hydrochloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acebutolol hydrochloride
Generic Name acebutolol hydrochloride
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

acebutolol hydrochloride 400 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-256
Product ID 62559-256_512c2032-4b9a-4b8c-b360-02f89d62714c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074007
Listing Expiration 2026-12-31
Marketing Start 2022-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559256
Hyphenated Format 62559-256

Supplemental Identifiers

RxCUI
998685 998689
UPC
0362559255011 0362559256018
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 ANDA074007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (62559-256-01)
source: ndc

Packages (1)

62559-256-01 100 CAPSULE in 1 BOTTLE (62559-256-01)

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": "512c2032-4b9a-4b8c-b360-02f89d62714c", "openfda": {"upc": ["0362559255011", "0362559256018"], "unii": ["B025Y34C54"], "rxcui": ["998685", "998689"], "spl_set_id": ["48bded12-09c7-47f2-b162-ec970a77f2d8"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62559-256-01)", "package_ndc": "62559-256-01", "marketing_start_date": "20220725"}], "brand_name": "Acebutolol Hydrochloride", "product_id": "62559-256_512c2032-4b9a-4b8c-b360-02f89d62714c", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "62559-256", "generic_name": "Acebutolol Hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acebutolol Hydrochloride", "active_ingredients": [{"name": "ACEBUTOLOL HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA074007", "marketing_category": "ANDA", "marketing_start_date": "20220725", "listing_expiration_date": "20261231"}