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United States · US · US:60505-4896_49718fe6-b8d0-6db9-e063-6294a90aa923

desogestrel and ethinyl estradiol

Orange BookSPL

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6050548961
    3 BLISTER PACK in 1 CARTON (60505-4896-1) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK

Annotations

Orange Book
A207067
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "9bb13b85-5d54-4689-b915-50b1da3a525b": {
      "match": "brand_token",
      "title": "DESOGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "1",
      "published_date": "2026-02-06"
    }
  },
  "productid": "60505-4896_49718fe6-b8d0-6db9-e063-6294a90aa923",
  "productndc": "60505-4896",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207067",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG;0.03MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "desogestrel and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA207067",
  "marketing_category": "ANDA",
  "nonproprietary_name": "desogestrel and ethinyl estradiol",
  "start_marketing_date": "20260205",
  "active_numerator_strength": null
}

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