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United States · US · US:27241-291_ec1b00c3-3d59-420a-a71c-e9bd9a8d02fd

Terazosin

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeG04CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2724129101
    100 CAPSULE in 1 BOTTLE (27241-291-01)
  • ndc11
    2724129110
    1000 CAPSULE in 1 BOTTLE (27241-291-10)

Annotations

UNII (FDA Substance ID)
D32S14F082
TERAZOSIN HYDROCHLORIDE
RxCUI 235224
Orange Book
A219482
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": "27241-291_ec1b00c3-3d59-420a-a71c-e9bd9a8d02fd",
  "productndc": "27241-291",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219482",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "May 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "May 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "May 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "May 12, 2025"
      }
    ],
    "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": "ANDA219482",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terazosin",
  "start_marketing_date": "20250512",
  "active_numerator_strength": "10"
}

Related drugs

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