Tri-Lo- 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
7070012085
3 BLISTER PACK in 1 CARTON (70700-120-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A091232

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "90f7ab24-7839-4408-9a74-07bb6a79eacc": {
      "match": "brand_token",
      "title": "TRI-LO- ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2024-05-23"
    }
  },
  "productid": "70700-120_b2a112e8-a8c4-2254-1046-9ee6263e66e1",
  "productndc": "70700-120",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tri-Lo- Estarylla",
  "active_ingred_unit": null,
  "application_number": "ANDA091232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20180101",
  "active_numerator_strength": null
}

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