Terazosin

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG04CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6318745690
90 CAPSULE in 1 BOTTLE (63187-456-90)

Annotations

UNII (FDA Substance ID)

D32S14F082

TERAZOSIN HYDROCHLORIDE

RxCUI 235224

Orange Book

A075317

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": "63187-456_ac54475d-30d6-4146-88e5-e073a08467c9",
  "productndc": "63187-456",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075317",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Dec 20, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Dec 20, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Dec 20, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Dec 20, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERAZOSIN HYDROCHLORIDE",
  "proprietary_name": "Terazosin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075317",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terazosin Hydrochloride",
  "start_marketing_date": "20041220",
  "active_numerator_strength": "5"
}

Related drugs

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