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United States · US · US:80425-0462_29ac720e-f2ab-f45b-e063-6394a90a165e

Trazodone Hydrochloride

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN06AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042504621
    30 TABLET in 1 BOTTLE (80425-0462-1)
  • ndc11
    8042504622
    60 TABLET in 1 BOTTLE (80425-0462-2)
  • ndc11
    8042504623
    90 TABLET in 1 BOTTLE (80425-0462-3)

Annotations

UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
A202180
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": "80425-0462_29ac720e-f2ab-f45b-e063-6394a90a165e",
  "productndc": "80425-0462",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202180",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Nov 27, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAZODONE HYDROCHLORIDE",
  "proprietary_name": "Trazodone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202180",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trazodone Hydrochloride",
  "start_marketing_date": "20241219",
  "active_numerator_strength": "150"
}

Related drugs

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