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United States · US · US:51662-1376_103515bd-ec41-5646-e063-6394a90ae3b4

HYDRALAZINE HYDROCHLORIDE

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC02DB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166213761
    1 mL in 1 VIAL, SINGLE-DOSE (51662-1376-1)
  • ndc11
    5166213763
    25 POUCH in 1 BOX (51662-1376-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1376-2) / 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": "51662-1376_103515bd-ec41-5646-e063-6394a90ae3b4",
  "productndc": "51662-1376",
  "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": "20191209",
  "active_numerator_strength": "20"
}

Related drugs

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