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United States · US · US:70700-115_9f57f11b-8425-7079-1c5c-cd2889945155

Syeda

Orange BookSPL

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

Identification

ManufacturerXiromed, LLC.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070011585
    3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A090114
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "4424505f-acae-43ba-8a75-eadd0e283b23": {
      "match": "brand_token",
      "title": "SYEDA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2024-01-12"
    }
  },
  "productid": "70700-115_9f57f11b-8425-7079-1c5c-cd2889945155",
  "productndc": "70700-115",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090114",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.03MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Syeda",
  "active_ingred_unit": null,
  "application_number": "ANDA090114",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Drospirenone and Ethinyl Estradiol",
  "start_marketing_date": "20171201",
  "active_numerator_strength": null
}

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