TRAZODONE HCL

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC

CountryUS (United States)

ATC codeN06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8042501761
30 TABLET in 1 BOTTLE (80425-0176-1)
ndc11
8042501762
60 TABLET in 1 BOTTLE (80425-0176-2)

Annotations

UNII (FDA Substance ID)

6E8ZO8LRNM

TRAZODONE HYDROCHLORIDE

RxCUI 82112

Orange Book

A205253

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6E8ZO8LRNM",
    "rxcui": "82112",
    "inchikey": "OHHDIOKRWWOXMT-UHFFFAOYSA-N",
    "display_name": "TRAZODONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "df17cec9-ad5e-4e57-8572-c927c9b955e2": {
      "match": "brand_token",
      "title": "TRAZODONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
      "spl_version": "30",
      "published_date": "2026-05-29"
    }
  },
  "productid": "80425-0176_2a99a7c1-c4c3-2b01-e063-6294a90aa3b8",
  "productndc": "80425-0176",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Oct 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Oct 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Oct 10, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Oct 10, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAZODONE HYDROCHLORIDE",
  "proprietary_name": "TRAZODONE HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRAZODONE HCL",
  "start_marketing_date": "20171211",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N06AX05.

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