HYDRALAZINE HYDROCHLORIDE

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC02DB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2315500301
100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01)
ndc11
2315500310
1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)

Annotations

UNII (FDA Substance ID)

FD171B778Y

HYDRALAZINE HYDROCHLORIDE

RxCUI 82027

Orange Book

A086242

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "FD171B778Y",
    "rxcui": "82027",
    "inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
    "display_name": "HYDRALAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a1066707-2391-4918-8ded-600c017fde48": {
      "match": "brand_token",
      "title": "HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "23155-003_e092716d-6522-4cfb-8728-622f9b553ef1",
  "productndc": "23155-003",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "086242",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 4, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Feb 4, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE",
  "proprietary_name": "HYDRALAZINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA086242",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydralazine hydrochloride",
  "start_marketing_date": "20070406",
  "active_numerator_strength": "50"
}

Related drugs

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