Levora

Orange BookSPL

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

Identification

ManufacturerMayne Pharma Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

Orange Book

A073594

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "31679b9f-58c9-4bf1-8c2c-f5a216ff4cd3": {
      "match": "brand_token",
      "title": "LEVORA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]",
      "spl_version": "10",
      "published_date": "2025-07-28"
    }
  },
  "productid": "51862-097_3aadc382-e2a4-019e-e063-6394a90a45c3",
  "productndc": "51862-097",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "073594",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Dec 13, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Levora",
  "active_ingred_unit": null,
  "application_number": "ANDA073594",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20160803",
  "active_numerator_strength": null
}

Access this data programmatically

Query Levora 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