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United States · US · US:51407-667_462fa6dd-0afc-9a7f-e063-6294a90a5055

Acebutolol Hydrochloride

Orange BookUNIISPLATC C07AB04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeC07AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5140766701
    100 CAPSULE in 1 BOTTLE (51407-667-01)

Annotations

UNII (FDA Substance ID)
B025Y34C54
ACEBUTOLOL HYDROCHLORIDE
RxCUI 142130
Orange Book
A074007
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": "51407-667_462fa6dd-0afc-9a7f-e063-6294a90a5055",
  "productndc": "51407-667",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074007",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Oct 18, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "002",
        "approval_date": "Oct 18, 1995"
      }
    ],
    "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": "ANDA074007",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acebutolol Hydrochloride",
  "start_marketing_date": "19951018",
  "active_numerator_strength": "400"
}

Related drugs

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