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United States · US · US:31722-945_05b50c53-ab5a-4a83-e063-6394a90a6214

Drospirenone and Ethinyl Estradiol

Orange BookSPL

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3172294531
    3 BLISTER PACK in 1 CARTON (31722-945-31) / 1 KIT in 1 BLISTER PACK (31722-945-28)
  • ndc11
    3172294532
    1 BLISTER PACK in 1 CARTON (31722-945-32) / 1 KIT in 1 BLISTER PACK (31722-945-28)

Annotations

Orange Book
A213034
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": "31722-945_05b50c53-ab5a-4a83-e063-6394a90a6214",
  "productndc": "31722-945",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213034",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "Jan 24, 2020"
      }
    ],
    "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": "ANDA213034",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Drospirenone and Ethinyl Estradiol",
  "start_marketing_date": "20200124",
  "active_numerator_strength": null
}

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