Trazodone Hydrochloride

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerCoupler LLC

CountryUS (United States)

ATC codeN06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6704615063
30 TABLET in 1 BLISTER PACK (67046-1506-3)

Annotations

UNII (FDA Substance ID)

6E8ZO8LRNM

TRAZODONE HYDROCHLORIDE

RxCUI 82112

Orange Book

A218988

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": "67046-1506_2cb18efa-16e1-b2f6-e063-6394a90a0d68",
  "productndc": "67046-1506",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218988",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 8, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 8, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Aug 8, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Aug 8, 2024"
      }
    ],
    "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": "ANDA218988",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trazodone Hydrochloride",
  "start_marketing_date": "20250124",
  "active_numerator_strength": "50"
}

Related drugs

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