Estradiol Valerate and Estradiol Valerate/Dienogest

Orange BookSPL

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

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781411015
3 BLISTER PACK in 1 PACKAGE (0781-4110-15) / 1 KIT in 1 BLISTER PACK (0781-4110-52)

Annotations

Orange Book

N022252

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "50c786d6-91bd-4eea-9455-ff2abc08372f": {
      "match": "brand_token",
      "title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0781-4110_ce80046e-2aca-4c57-af85-d985e3ae769f",
  "productndc": "0781-4110",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022252",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A",
        "product_no": "001",
        "approval_date": "May 6, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Estradiol Valerate and Estradiol Valerate/Dienogest",
  "active_ingred_unit": null,
  "application_number": "NDA022252",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "estradiol valerate and estradiol valerate/dienogest",
  "start_marketing_date": "20150805",
  "active_numerator_strength": null
}

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