Hydralazine Hydrochloride

Orange BookUNIISPLATC C02DB02

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC02DB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3172251901
100 TABLET in 1 BOTTLE (31722-519-01)
ndc11
3172251905
500 TABLET in 1 BOTTLE (31722-519-05)
ndc11
3172251910
1000 TABLET in 1 BOTTLE (31722-519-10)

Annotations

UNII (FDA Substance ID)

FD171B778Y

HYDRALAZINE HYDROCHLORIDE

RxCUI 82027

Orange Book

A040901

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": "31722-519_30381b85-deb3-bc70-e063-6294a90ad921",
  "productndc": "31722-519",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040901",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Sep 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Sep 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Sep 12, 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": "ANDA040901",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydralazine Hydrochloride",
  "start_marketing_date": "20100101",
  "active_numerator_strength": "10"
}

Related drugs

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