Estarylla

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerXiromed, LLC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070011985
3 BLISTER PACK in 1 CARTON (70700-119-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A090794

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "7acde5ef-f457-4c47-897b-d048194c7d7e": {
      "match": "brand_token",
      "title": "ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2024-10-17"
    }
  },
  "productid": "70700-119_3549d0b1-c150-b3ab-8af6-ba777ffc229a",
  "productndc": "70700-119",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Estarylla",
  "active_ingred_unit": null,
  "application_number": "ANDA090794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and ethinyl estradiol",
  "start_marketing_date": "20180101",
  "active_numerator_strength": null
}

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