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United States · US · US:68180-844_8f9181bf-d2bd-422c-a115-0adfaacd0c9f

Kurvelo

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
    6818084473
    3 BLISTER PACK in 1 CARTON (68180-844-73) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74)

Annotations

Orange Book
A091408
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "752f525e-1838-4058-9ab7-2c2d91f86dfd": {
      "match": "brand_token",
      "title": "KURVELO (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "12",
      "published_date": "2026-05-26"
    }
  },
  "productid": "68180-844_8f9181bf-d2bd-422c-a115-0adfaacd0c9f",
  "productndc": "68180-844",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091408",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Oct 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Kurvelo",
  "active_ingred_unit": null,
  "application_number": "ANDA091408",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20210207",
  "active_numerator_strength": null
}

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