Trazodone Hydrochloride

Orange BookUNIISPLATC N06AX05

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeN06AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807129969
90 TABLET in 1 BOTTLE (68071-2996-9)

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": "68071-2996_2d53e488-a013-123b-e063-6294a90aa8ef",
  "productndc": "68071-2996",
  "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": "20131127",
  "active_numerator_strength": "50"
}

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