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United States · US · US:68180-739_fe68188c-4369-4e86-9bb4-2b5d01ff2594

ENSKYCE

Orange BookSPL

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

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
    6818073973
    3 POUCH in 1 CARTON (68180-739-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-787-74) * 7 TABLET in 1 BLISTER PACK (68180-794-74)

Annotations

Orange Book
A201887
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "799fa1d8-4e7b-4b5e-844d-d638896a4b02": {
      "match": "brand_token",
      "title": "ENSKYCE (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2025-12-16"
    }
  },
  "productid": "68180-739_fe68188c-4369-4e86-9bb4-2b5d01ff2594",
  "productndc": "68180-739",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201887",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG;0.03MG",
        "product_no": "001",
        "approval_date": "Mar 7, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ENSKYCE",
  "active_ingred_unit": null,
  "application_number": "ANDA201887",
  "marketing_category": "ANDA",
  "nonproprietary_name": "desogestrel and ethinyl estradiol",
  "start_marketing_date": "20241210",
  "active_numerator_strength": null
}

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