levonorgestrel and ethinyl estradiol

Orange BookSPL

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

Identification

ManufacturerAcella Pharmaceuticals

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4219262303
3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK
ndc11
4219262328
1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N208612

AB3

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "18c143b6-2f83-4dcb-b84a-855739212f25": {
      "match": "brand_token",
      "title": "LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "1",
      "published_date": "2026-04-06"
    }
  },
  "productid": "42192-623_18a7ed1f-bfc1-476c-9550-77f80f5feeac",
  "productndc": "42192-623",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208612",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "levonorgestrel and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "NDA208612",
  "marketing_category": "NDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20230821",
  "active_numerator_strength": null
}

Access this data programmatically

Query levonorgestrel and ethinyl estradiol 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