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United States · US · US:50419-405_4f14f9c9-411b-48b0-a3d3-cac639cdfb8b

Yaz

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
    5041940503
    3 BLISTER PACK in 1 PACKAGE (50419-405-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
N021676
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "065f33e4-b587-4e66-b896-ca9ab7b7c876": {
      "match": "brand_token",
      "title": "YAZ (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "21",
      "published_date": "2025-08-14"
    }
  },
  "productid": "50419-405_4f14f9c9-411b-48b0-a3d3-cac639cdfb8b",
  "productndc": "50419-405",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021676",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Yaz",
  "active_ingred_unit": null,
  "application_number": "NDA021676",
  "marketing_category": "NDA",
  "nonproprietary_name": "Drospirenone and ethinyl estradiol",
  "start_marketing_date": "20060316",
  "active_numerator_strength": null
}

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