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United States · US · US:71335-3131_12aa9f2d-da1f-43cf-a446-65c90c0503df

Terazosin

Orange BookUNIISPLATC G04CA03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7133531311
    100 CAPSULE in 1 BOTTLE (71335-3131-1)
  • ndc11
    7133531312
    30 CAPSULE in 1 BOTTLE (71335-3131-2)
  • ndc11
    7133531313
    90 CAPSULE in 1 BOTTLE (71335-3131-3)
  • ndc11
    7133531314
    60 CAPSULE in 1 BOTTLE (71335-3131-4)

Annotations

UNII (FDA Substance ID)
D32S14F082
TERAZOSIN HYDROCHLORIDE
RxCUI 235224
Orange Book
A075667
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": "71335-3131_12aa9f2d-da1f-43cf-a446-65c90c0503df",
  "productndc": "71335-3131",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jul 28, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jul 28, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jul 28, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Jul 28, 2000"
      }
    ],
    "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": "ANDA075667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Terazosin",
  "start_marketing_date": "20240311",
  "active_numerator_strength": "5"
}

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