Femynor

Orange BookSPL

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923815516
1 BLISTER PACK in 1 CARTON (69238-1551-6) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A203865

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "59bce25b-ee2c-4f06-afff-e5141d063602": {
      "match": "brand_token",
      "title": "FEMYNOR (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "9",
      "published_date": "2024-01-01"
    }
  },
  "productid": "69238-1551_a123a86f-1a2a-4e89-9627-1bbcf9f237d2",
  "productndc": "69238-1551",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203865",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Femynor",
  "active_ingred_unit": null,
  "application_number": "ANDA203865",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20160615",
  "active_numerator_strength": null
}

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