Vardenafil Hydrochloride

Orange BookUNIISPLATC G04BE09

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04BE09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7216222353
30 TABLET in 1 BOTTLE (72162-2235-3)

Annotations

UNII (FDA Substance ID)

5M8S2CU0TS

VARDENAFIL HYDROCHLORIDE

RxCUI 307306

Orange Book

A209057

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": "72162-2235_cecc1421-aaad-44e4-9358-1535d77fc2ec",
  "productndc": "72162-2235",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209057",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Oct 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Oct 31, 2018"
      }
    ],
    "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": "ANDA209057",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vardenafil Hydrochloride",
  "start_marketing_date": "20181101",
  "active_numerator_strength": "10"
}

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