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United States · US · US:60505-2659_6761bdb4-2041-118d-35a8-4c39a8b20539

Trazodone Hydrochloride

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerApotex Corp
CountryUS (United States)
ATC codeN06AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6050526591
    100 TABLET in 1 BOTTLE (60505-2659-1)
  • ndc11
    6050526595
    500 TABLET in 1 BOTTLE (60505-2659-5)
  • ndc11
    6050526597
    1400 TABLET in 1 BOTTLE (60505-2659-7)

Annotations

UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
A071196
ABABAB
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": "60505-2659_6761bdb4-2041-118d-35a8-4c39a8b20539",
  "productndc": "60505-2659",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071196",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 25, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Apr 26, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Apr 26, 1999"
      }
    ],
    "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": "ANDA071196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trazodone Hydrochloride",
  "start_marketing_date": "20090105",
  "active_numerator_strength": "300"
}

Related drugs

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