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United States · US · US:31722-934_0b315373-6447-52e5-e063-6294a90a448c

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
    3172293431
    1 BLISTER PACK in 1 CARTON (31722-934-31) / 1 KIT in 1 BLISTER PACK
  • ndc11
    3172293432
    3 BLISTER PACK in 1 CARTON (31722-934-32) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A211944
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": "31722-934_0b315373-6447-52e5-e063-6294a90a448c",
  "productndc": "31722-934",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211944",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2019"
      }
    ],
    "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": "ANDA211944",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Drospirenone and ethinyl estradiol",
  "start_marketing_date": "20190322",
  "active_numerator_strength": null
}

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