vilazodone hydrochloride

Orange BookUNIISPLATC N06AX24

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC

CountryUS (United States)

ATC codeN06AX24

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7220526230
30 TABLET in 1 BOTTLE (72205-262-30)

Annotations

UNII (FDA Substance ID)

U8HTX2GK8J

VILAZODONE HYDROCHLORIDE

RxCUI 1086768

Orange Book

A208228

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "U8HTX2GK8J",
    "rxcui": "1086768",
    "inchikey": "RPZBRGFNBNQSOP-UHFFFAOYSA-N",
    "display_name": "VILAZODONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "061efdcc-40ea-4647-8cc8-01cd1ccca68b": {
      "match": "brand_token",
      "title": "VILAZODONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "72205-262_c3e167cd-7f56-45eb-80df-a60fa1392e57",
  "productndc": "72205-262",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208228",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jul 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jul 7, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VILAZODONE HYDROCHLORIDE",
  "proprietary_name": "vilazodone hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208228",
  "marketing_category": "ANDA",
  "nonproprietary_name": "vilazodone hydrochloride",
  "start_marketing_date": "20230707",
  "active_numerator_strength": "40"
}

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