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United States · US · US:67046-1678_52ce0743-6b88-a3a5-e063-6294a90a5783

Prazosin Hydrochloride

In shortageOrange BookUNIISPLATC C02CA01

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

Identification

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

Packs · 1

  • ndc11
    6704616783
    30 CAPSULE in 1 BLISTER PACK (67046-1678-3)

Annotations

UNII (FDA Substance ID)
X0Z7454B90
PRAZOSIN HYDROCHLORIDE
RxCUI 203210
Orange Book
A213052
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": "67046-1678_52ce0743-6b88-a3a5-e063-6294a90a5783",
  "productndc": "67046-1678",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213052",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Mar 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Mar 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Mar 31, 2023"
      }
    ],
    "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": "ANDA213052",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prazosin Hydrochloride",
  "start_marketing_date": "20260527",
  "active_numerator_strength": "5"
}

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