Estarylla

Orange BookSPL

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8280415828
1 BLISTER PACK in 1 POUCH (82804-158-28) / 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": "82804-158_7acde5ef-f457-4c47-897b-d048194c7d7e",
  "productndc": "82804-158",
  "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
}

Access this data programmatically

Query Estarylla and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs