Vardenafil Hydrochloride

Orange BookUNIISPLATC G04BE09

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeG04BE09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093765356
30 TABLET, FILM COATED in 1 BOTTLE (0093-7653-56)

Annotations

UNII (FDA Substance ID)

5M8S2CU0TS

VARDENAFIL HYDROCHLORIDE

RxCUI 307306

Orange Book

A091347

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5M8S2CU0TS",
    "rxcui": "307306",
    "inchikey": "FBCDRHDULQYRTB-UHFFFAOYSA-N",
    "display_name": "VARDENAFIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "80c4793d-e19e-10f0-e053-2991aa0a4620": {
      "match": "brand_token",
      "title": "VARDENAFIL HYDROCHLORIDE TABLET [AVKARE]",
      "spl_version": "5",
      "published_date": "2026-01-16"
    }
  },
  "productid": "0093-7653_51f4534a-5b11-490a-9e0b-ac681150967f",
  "productndc": "0093-7653",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091347",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "May 3, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "May 3, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "May 3, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "May 3, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARDENAFIL HYDROCHLORIDE",
  "proprietary_name": "Vardenafil Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091347",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vardenafil Hydrochloride",
  "start_marketing_date": "20190103",
  "active_numerator_strength": "5"
}

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