Simpesse

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6586286495
2 POUCH in 1 CARTON (65862-864-95) / 1 BLISTER PACK in 1 POUCH (65862-864-94) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A206851

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "abea62b3-6a55-40a4-9e68-1ee9801e0f2c": {
      "match": "brand_token",
      "title": "SIMPESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "12",
      "published_date": "2025-08-08"
    }
  },
  "productid": "65862-864_bd9d6e25-de56-422b-9155-89378c5b943f",
  "productndc": "65862-864",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206851",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG,0.01MG;0.15MG,N/A",
        "product_no": "001",
        "approval_date": "Apr 7, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Simpesse",
  "active_ingred_unit": null,
  "application_number": "ANDA206851",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20170407",
  "active_numerator_strength": null
}

Access this data programmatically

Query Simpesse 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