Varophen

Orange BookSPL

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

Identification

ManufacturerV2 Pharma, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7283520102
1 KIT in 1 CARTON (72835-201-02) * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE

Annotations

Orange Book

A202027

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "1bef5035-70ad-4f75-80c3-6252cd01fa85": {
      "match": "brand_token",
      "title": "VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]",
      "spl_version": "5",
      "published_date": "2025-01-01"
    }
  },
  "productid": "72835-201_6083c25c-8acf-4705-871e-28aafe45944d",
  "productndc": "72835-201",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202027",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5%",
        "product_no": "001",
        "approval_date": "May 27, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Varophen",
  "active_ingred_unit": null,
  "application_number": "ANDA202027",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium and Menthol, Methyl salicylate",
  "start_marketing_date": "20190603",
  "active_numerator_strength": null
}

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