Norethindrone Acetate and Ethinyl Estradiol

Orange BookSPL

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

Identification

ManufacturerXiromed, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070010185
3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A209609

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
      "match": "brand_token",
      "title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "7",
      "published_date": "2026-03-27"
    }
  },
  "productid": "70700-101_0b7a2fac-2281-4c64-29aa-5e0d05d49236",
  "productndc": "70700-101",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Jul 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA209609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets",
  "start_marketing_date": "20180824",
  "active_numerator_strength": null
}

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