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United States · US · US:68180-886_d5033102-e177-4057-bf0d-d7df320d59e9

Nikki

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
    6818088673
    3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A201661
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "9aff6034-044c-466d-bf52-18a998d47f66": {
      "match": "brand_token",
      "title": "NIKKI ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "8",
      "published_date": "2025-12-09"
    }
  },
  "productid": "68180-886_d5033102-e177-4057-bf0d-d7df320d59e9",
  "productndc": "68180-886",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201661",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "May 27, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nikki",
  "active_ingred_unit": null,
  "application_number": "ANDA201661",
  "marketing_category": "ANDA",
  "nonproprietary_name": "drospirenone and ethinyl estradiol",
  "start_marketing_date": "20191130",
  "active_numerator_strength": null
}

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