LEVONORGESTREL AND ETHINYL ESTRADIOL

Orange BookSPL

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378655053
3 POUCH in 1 CARTON (0378-6550-53) / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A091663

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": "0378-6550_feeae783-e2d6-4d6f-9815-627228a6b23b",
  "productndc": "0378-6550",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091663",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LEVONORGESTREL AND ETHINYL ESTRADIOL",
  "active_ingred_unit": null,
  "application_number": "ANDA091663",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20130816",
  "active_numerator_strength": null
}

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