Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate

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
6021910317
3 BLISTER PACK in 1 CARTON (60219-1031-7) / 1 KIT in 1 BLISTER PACK (60219-1031-6)

Annotations

Orange Book

A207514

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "60219-1031_ae13db8f-27e2-420a-b909-99d0347e6286",
  "productndc": "60219-1031",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207514",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Sep 11, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
  "active_ingred_unit": null,
  "application_number": "ANDA207514",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
  "start_marketing_date": "20170921",
  "active_numerator_strength": null
}

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