Acebutolol Hydrochloride

Orange BookUNIISPLATC C07AB04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeC07AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026805015
50 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11)

Annotations

UNII (FDA Substance ID)

B025Y34C54

ACEBUTOLOL HYDROCHLORIDE

RxCUI 142130

Orange Book

A075047

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "B025Y34C54",
    "rxcui": "142130",
    "inchikey": "KTUFKADDDORSSI-UHFFFAOYSA-N",
    "display_name": "ACEBUTOLOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "28f8c26c-a1e1-4485-a45f-05c82f7a34b5": {
      "match": "brand_token",
      "title": "ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "14",
      "published_date": "2026-05-04"
    }
  },
  "productid": "50268-050_3f158c97-90b4-1c5e-e063-6294a90a6a65",
  "productndc": "50268-050",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075047",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Dec 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACEBUTOLOL HYDROCHLORIDE",
  "proprietary_name": "Acebutolol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acebutolol Hydrochloride",
  "start_marketing_date": "20100916",
  "active_numerator_strength": "200"
}

Related drugs

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