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
6846273329
3 BLISTER PACK in 1 CARTON (68462-733-29) / 1 KIT in 1 BLISTER PACK (68462-733-84)

Annotations

Orange Book

A204848

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": "68462-733_d9639734-d1a5-4fbf-95b9-3f4f70dd961b",
  "productndc": "68462-733",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204848",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2016"
      }
    ],
    "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": "ANDA204848",
  "marketing_category": "ANDA",
  "nonproprietary_name": "drospirenone and ethinyl estradiol",
  "start_marketing_date": "20160325",
  "active_numerator_strength": null
}

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