Prazosin Hydrochloride

In shortageOrange BookUNIISPLATC C02CA01

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

Identification

ManufacturerMarlex Pharmaceuticals Inc

CountryUS (United States)

ATC codeC02CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1013566801
100 CAPSULE in 1 BOTTLE (10135-668-01)
ndc11
1013566869
250 CAPSULE in 1 BOTTLE (10135-668-69)

Annotations

UNII (FDA Substance ID)

X0Z7454B90

PRAZOSIN HYDROCHLORIDE

RxCUI 203210

Orange Book

A210971

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": "10135-668_441dd676-fc13-c6ce-e063-6294a90a82a7",
  "productndc": "10135-668",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210971",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Oct 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Oct 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Oct 3, 2018"
      }
    ],
    "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": "ANDA210971",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prazosin Hydrochloride",
  "start_marketing_date": "20181001",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code C02CA01.

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