HydrALAZINE Hydrochloride

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC02DB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4335320505
4200 TABLET in 1 BOTTLE (43353-205-05)

Annotations

UNII (FDA Substance ID)

FD171B778Y

HYDRALAZINE HYDROCHLORIDE

RxCUI 82027

Orange Book

A090255

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": "43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c",
  "productndc": "43353-205",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090255",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Dec 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Dec 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Dec 15, 2008"
      }
    ],
    "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": "ANDA090255",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HydrALAZINE Hydrochloride",
  "start_marketing_date": "20160520",
  "active_numerator_strength": "100"
}

Related drugs

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