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United States · US · US:71205-144_283475ff-3b56-482c-b11b-a20f8a4661d3

drospirenone and ethinyl estradiol

Orange BookSPL

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7120514428
    3 BLISTER PACK in 1 CARTON (71205-144-28) / 1 KIT in 1 BLISTER PACK

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": "71205-144_283475ff-3b56-482c-b11b-a20f8a4661d3",
  "productndc": "71205-144",
  "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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