Vilazodone hydrochloride

Orange BookUNIISPLATC N06AX24

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeN06AX24

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909798102
30 TABLET, FILM COATED in 1 BOTTLE (69097-981-02)

Annotations

UNII (FDA Substance ID)

U8HTX2GK8J

VILAZODONE HYDROCHLORIDE

RxCUI 1086768

Orange Book

A208200

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": "69097-981_e16f2d8b-a5ec-498f-97c4-d1c9d897140f",
  "productndc": "69097-981",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208200",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Apr 7, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 6, 2022"
      }
    ],
    "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": "ANDA208200",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vilazodone hydrochloride",
  "start_marketing_date": "20230123",
  "active_numerator_strength": "20"
}

Related drugs

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