Junel Fe 1/20

Orange BookSPL

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6878868322
6 BLISTER PACK in 1 CARTON (68788-6832-2) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A076081

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "93a2f8c9-3550-42ec-8f76-3ac9badf4bb2": {
      "match": "brand_token",
      "title": "JUNEL FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "18",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68788-6832_01765aa5-7e4e-45b9-bd18-3c692c36c958",
  "productndc": "68788-6832",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "076081",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Junel Fe 1/20",
  "active_ingred_unit": null,
  "application_number": "ANDA076081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol, and ferrous fumarate",
  "start_marketing_date": "20161121",
  "active_numerator_strength": null
}

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