Back to search
🇺🇸

United States · US · US:0404-9787_e1a12f59-87d5-4b78-8405-e0c6a3e4369e

Hydralazine Hydrochloride

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeC02DB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0404978701
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A040388
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "0404-9787_e1a12f59-87d5-4b78-8405-e0c6a3e4369e",
  "productndc": "0404-9787",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "040388",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Mar 13, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE",
  "proprietary_name": "Hydralazine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040388",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HYDRALAZINE HYDROCHLORIDE",
  "start_marketing_date": "20250410",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C02DB02.

Access this data programmatically

Query Hydralazine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.