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United States · US · US:50419-402_84c4a6e5-8157-4f6d-a51f-3665e8568a3c

Yasmin

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    5041940203
    3 BLISTER PACK in 1 PACKAGE (50419-402-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
N021098
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "d7ea6a60-5a56-4f81-b206-9b27b7e58875": {
      "match": "brand_token",
      "title": "YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "21",
      "published_date": "2024-11-22"
    }
  },
  "productid": "50419-402_84c4a6e5-8157-4f6d-a51f-3665e8568a3c",
  "productndc": "50419-402",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021098",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "May 11, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Yasmin",
  "active_ingred_unit": null,
  "application_number": "NDA021098",
  "marketing_category": "NDA",
  "nonproprietary_name": "drospirenone and ethinyl estradiol",
  "start_marketing_date": "20010511",
  "active_numerator_strength": null
}

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