Levonorgestrel and Ethinyl Estradiol

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6818085773
3 CARTON in 1 CARTON (68180-857-73) / 1 KIT in 1 CARTON

Annotations

Orange Book

A200248

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": "68180-857_2cc1d4cc-8398-4ed8-bca0-313c99e8aeef",
  "productndc": "68180-857",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG",
        "product_no": "001",
        "approval_date": "Nov 19, 2015"
      }
    ],
    "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": "ANDA200248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20200830",
  "active_numerator_strength": null
}

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