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United States · US · US:48433-084_4f0c392d-3ce9-d8e7-e063-6294a90a2005

Prazosin Hydrochloride

In shortageOrange BookUNIISPLATC C02CA01

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

Identification

ManufacturerSafecor Health LLC
CountryUS (United States)
ATC codeC02CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4843308420
    100 BLISTER PACK in 1 CARTON (48433-084-20) / 1 CAPSULE in 1 BLISTER PACK (48433-084-01)

Annotations

UNII (FDA Substance ID)
X0Z7454B90
PRAZOSIN HYDROCHLORIDE
RxCUI 203210
Orange Book
A072575
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Prazosin Hydrochloride Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "X0Z7454B90",
    "rxcui": "203210",
    "inchikey": "WFXFYZULCQKPIP-UHFFFAOYSA-N",
    "display_name": "PRAZOSIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52ce82b0-3cb5-b5b2-e063-6394a90a9f12": {
      "match": "brand_token",
      "title": "PRAZOSIN HYDROCHLORIDE CAPSULE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "48433-084_4f0c392d-3ce9-d8e7-e063-6294a90a2005",
  "productndc": "48433-084",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "072575",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "May 16, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "May 16, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "003",
        "approval_date": "May 16, 1989"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAZOSIN HYDROCHLORIDE",
  "shortage_reason": "Prazosin Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Prazosin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072575",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prazosin hydrochloride",
  "start_marketing_date": "20260325",
  "active_numerator_strength": "1"
}

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