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United States · US · US:68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2

DROSPIRENONE AND ETHINYL ESTRADIOL

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
    6818086873
    3 POUCH in 1 CARTON (68180-868-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (68180-913-74) * 21 TABLET in 1 BLISTER PACK (68180-912-74)

Annotations

Orange Book
A201663
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "9187a357-e95d-4733-9627-f19522b86373": {
      "match": "brand_token",
      "title": "DROSPIRENONE AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "3",
      "published_date": "2026-05-15"
    }
  },
  "productid": "68180-868_3c3a2ddd-8711-416c-813e-63c64f579ac2",
  "productndc": "68180-868",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "Dec 18, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "DROSPIRENONE AND ETHINYL ESTRADIOL",
  "active_ingred_unit": null,
  "application_number": "ANDA201663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DROSPIRENONE AND ETHINYL ESTRADIOL",
  "start_marketing_date": "20220415",
  "active_numerator_strength": null
}

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