Terazosin Hydrochloride

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeG04CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7161059560
90 CAPSULE in 1 BOTTLE (71610-595-60)
ndc11
7161059580
180 CAPSULE in 1 BOTTLE (71610-595-80)

Annotations

UNII (FDA Substance ID)

D32S14F082

TERAZOSIN HYDROCHLORIDE

RxCUI 235224

Orange Book

A074823

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "D32S14F082",
    "rxcui": "235224",
    "inchikey": "NZMOFYDMGFQZLS-UHFFFAOYSA-N",
    "display_name": "TERAZOSIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b77a4a38-edb1-412e-97af-d49e862b32c1": {
      "match": "brand_token",
      "title": "TERAZOSIN CAPSULE [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-25"
    }
  },
  "productid": "71610-595_2b26376c-c9c8-4d68-aec5-f3aa773fe7f9",
  "productndc": "71610-595",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074823",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Mar 30, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Mar 30, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Mar 30, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Mar 30, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERAZOSIN HYDROCHLORIDE",
  "proprietary_name": "Terazosin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074823",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terazosin Hydrochloride",
  "start_marketing_date": "20200630",
  "active_numerator_strength": "5"
}

Related drugs

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