Loestrin

Orange BookSPL

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

Identification

ManufacturerTeva Women's Health LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5128512870
5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A076064

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "f29ebcb5-7e65-4092-bfaa-f5ec026fc255": {
      "match": "brand_token",
      "title": "LOESTRIN 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET LOESTRIN FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH LLC]",
      "spl_version": "12",
      "published_date": "2025-04-16"
    }
  },
  "productid": "51285-128_21f0dbf2-f0a8-447a-a975-482b4194b1eb",
  "productndc": "51285-128",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "076064",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;1.5MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Loestrin",
  "active_ingred_unit": null,
  "application_number": "ANDA076064",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
  "start_marketing_date": "20150226",
  "active_numerator_strength": null
}

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