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United States · US · US:0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddf

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378730353
    3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)

Annotations

Orange Book
A205069
AB
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": "0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddf",
  "productndc": "0378-7303",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205069",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG,0.03MG,0.035MG;1MG,1MG,1MG",
        "product_no": "001",
        "approval_date": "Jun 22, 2018"
      }
    ],
    "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": "ANDA205069",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20220727",
  "active_numerator_strength": null
}

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