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United States · US · US:50090-2594_5084730b-7ef0-4c7a-aee4-5cc8f430b768

drospirenone and ethinyl estradiol

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
    5009025940
    1 KIT in 1 KIT (50090-2594-0)

Annotations

Orange Book
A204296
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "9187a357-e95d-4733-9627-f19522b86373": {
      "match": "brand_token",
      "title": "DROSPIRENONE AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "3",
      "published_date": "2026-05-15"
    }
  },
  "productid": "50090-2594_5084730b-7ef0-4c7a-aee4-5cc8f430b768",
  "productndc": "50090-2594",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204296",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "drospirenone and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA204296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "drospirenone and ethinyl estradiol",
  "start_marketing_date": "20150817",
  "active_numerator_strength": null
}

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