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United States · US · US:51655-915_49741c96-db68-402a-e063-6394a90a07e4

terazosin

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeG04CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5165591552
    30 CAPSULE in 1 BOTTLE, PLASTIC (51655-915-52)

Annotations

UNII (FDA Substance ID)
D32S14F082
TERAZOSIN HYDROCHLORIDE
RxCUI 235224
Orange Book
A075614
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": "51655-915_49741c96-db68-402a-e063-6394a90a07e4",
  "productndc": "51655-915",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075614",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 30, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jan 30, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jan 30, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Jan 30, 2001"
      }
    ],
    "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": "ANDA075614",
  "marketing_category": "ANDA",
  "nonproprietary_name": "terazosin",
  "start_marketing_date": "20230626",
  "active_numerator_strength": "2"
}

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