Terazosin Hydrochloride

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerAmici Pharma, Inc.

CountryUS (United States)

ATC codeG04CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6929220401
100 CAPSULE in 1 BOTTLE (69292-204-01)
ndc11
6929220410
1000 CAPSULE in 1 BOTTLE (69292-204-10)

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": "69292-204_0562ff47-168b-44ba-8214-b63f98da2cad",
  "productndc": "69292-204",
  "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": "20260520",
  "active_numerator_strength": "10"
}

Related drugs

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