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United States · US · US:62332-235_33bb2a69-79e4-49bb-9388-97367b428639

Vardenafil

Orange BookSPLATC G04BE09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6233223504
    4 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

Orange Book
A208324
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "62332-235_33bb2a69-79e4-49bb-9388-97367b428639",
  "productndc": "62332-235",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "208324",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE",
  "proprietary_name": "Vardenafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vardenafil",
  "start_marketing_date": "20181120",
  "active_numerator_strength": "10"
}

Related drugs

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