Levonorgestrel and Ethinyl Estradiol

Orange BookSPL

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050548988
3 BLISTER PACK in 1 CARTON (60505-4898-8) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A207065

AB1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "18c143b6-2f83-4dcb-b84a-855739212f25": {
      "match": "brand_token",
      "title": "LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "1",
      "published_date": "2026-04-06"
    }
  },
  "productid": "60505-4898_4ea39445-1e59-ac2e-e063-6294a90a61ba",
  "productndc": "60505-4898",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207065",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA207065",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20260404",
  "active_numerator_strength": null
}

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