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United States · US · US:50419-407_2a018ffb-3fc6-41db-83b3-6e159cd446c3

Beyaz

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 · 4

  • ndc11
    5041940700
    90 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5041940703
    3 BLISTER PACK in 1 PACKAGE (50419-407-03) / 1 KIT in 1 BLISTER PACK (50419-407-01)
  • ndc11
    5041940770
    90 BLISTER PACK in 1 PACKAGE (50419-407-70) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5041940775
    12 PACKAGE in 1 CARTON (50419-407-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-407-71)

Annotations

Orange Book
N022532
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "8132454a-6135-4bac-b206-83a55eb8dbc6": {
      "match": "brand_token",
      "title": "BEYAZ (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "23",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50419-407_2a018ffb-3fc6-41db-83b3-6e159cd446c3",
  "productndc": "50419-407",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022532",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG,N/A;0.02MG,N/A;0.451MG,0.451MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Beyaz",
  "active_ingred_unit": null,
  "application_number": "NDA022532",
  "marketing_category": "NDA",
  "nonproprietary_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium",
  "start_marketing_date": "20101007",
  "active_numerator_strength": null
}

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