Hydralazine Hydrochloride

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeC02DB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068782201
100 BLISTER PACK in 1 CARTON (60687-822-01) / 1 TABLET in 1 BLISTER PACK (60687-822-11)

Annotations

UNII (FDA Substance ID)

FD171B778Y

HYDRALAZINE HYDROCHLORIDE

RxCUI 82027

Orange Book

A040858

AAAAAAAA

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": "60687-822_22cbafb8-fd5b-19b1-e063-6394a90a2b4e",
  "productndc": "60687-822",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 26, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 26, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Feb 26, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Feb 26, 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": "ANDA040858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydralazine Hydrochloride",
  "start_marketing_date": "20240402",
  "active_numerator_strength": "25"
}

Related drugs

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