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United States · US · US:68788-7166_415a73bb-c5ea-43a6-a8dc-eb8ee8a53c9b

Trazodone Hydrochloride

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6878871661
    100 TABLET in 1 BOTTLE (68788-7166-1)
  • ndc11
    6878871663
    30 TABLET in 1 BOTTLE (68788-7166-3)
  • ndc11
    6878871666
    60 TABLET in 1 BOTTLE (68788-7166-6)
  • ndc11
    6878871669
    90 TABLET in 1 BOTTLE (68788-7166-9)

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": "68788-7166_415a73bb-c5ea-43a6-a8dc-eb8ee8a53c9b",
  "productndc": "68788-7166",
  "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trazodone Hydrochloride",
  "start_marketing_date": "20180605",
  "active_numerator_strength": "150"
}

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