drospirenone and ethinyl estradiol

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846272029
3 BLISTER PACK in 1 CARTON (68462-720-29) / 1 KIT in 1 BLISTER PACK (68462-720-84)

Annotations

Orange Book

A204296

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": "68462-720_69e71801-eff9-4165-8a4a-09bef29e0f3f",
  "productndc": "68462-720",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204296",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2015"
      }
    ],
    "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": "ANDA204296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "drospirenone and ethinyl estradiol",
  "start_marketing_date": "20150817",
  "active_numerator_strength": null
}

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