ETHYNODIOL DIACETATE 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
0378730653
3 POUCH in 1 CARTON (0378-7306-53) / 1 BLISTER PACK in 1 POUCH (0378-7306-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A204704

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "47263647-a9ac-40e4-83c0-d6500fa458cd": {
      "match": "brand_token",
      "title": "ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "7",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0378-7306_5a41f798-a26d-2f6f-7c2e-a3e74077a6d9",
  "productndc": "0378-7306",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204704",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05MG;1MG",
        "product_no": "001",
        "approval_date": "Feb 9, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL",
  "active_ingred_unit": null,
  "application_number": "ANDA204704",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ethynodiol diacetate and ethinyl estradiol",
  "start_marketing_date": "20161130",
  "active_numerator_strength": null
}

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