acebutolol hydrochloride

Generic: acebutolol hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

acebutolol hydrochloride 200 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-050
Product ID 50268-050_3f158c97-90b4-1c5e-e063-6294a90a6a65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075047
Listing Expiration 2026-12-31
Marketing Start 2010-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268050
Hyphenated Format 50268-050

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
  • 50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11)
source: ndc

Packages (1)

50268-050-15 50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11)

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": "3f158c97-90b4-1c5e-e063-6294a90a6a65", "openfda": {"unii": ["B025Y34C54"], "rxcui": ["998689"], "spl_set_id": ["ff68a002-d46d-4f9f-0705-427844ea3655"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-050-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-050-11)", "package_ndc": "50268-050-15", "marketing_start_date": "20100916"}], "brand_name": "Acebutolol Hydrochloride", "product_id": "50268-050_3f158c97-90b4-1c5e-e063-6294a90a6a65", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50268-050", "generic_name": "Acebutolol Hydrochloride", "labeler_name": "AvPAK", "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": "20100916", "listing_expiration_date": "20261231"}