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United States · US · US:50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318

VIORELE

Orange BookSPL

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009013950
    1 KIT in 1 KIT (50090-1395-0)

Annotations

Orange Book
A091346
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "39988aa6-8f68-40e8-9bdd-c40a3bdaad61": {
      "match": "brand_token",
      "title": "VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "17",
      "published_date": "2026-02-02"
    }
  },
  "productid": "50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318",
  "productndc": "50090-1395",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091346",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG,N/A;0.02MG,0.01MG",
        "product_no": "001",
        "approval_date": "Apr 2, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VIORELE",
  "active_ingred_unit": null,
  "application_number": "ANDA091346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20120404",
  "active_numerator_strength": null
}

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