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United States · US · US:50090-3229_504c5166-e2ca-4a75-bb6a-02798584ca64

Nortrel

Orange BookSPL

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009032290
    1 KIT in 1 KIT (50090-3229-0)

Annotations

Orange Book
A072695
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "140c50d6-c931-423a-9aa0-526eae7ab93c": {
      "match": "brand_token",
      "title": "NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "16",
      "published_date": "2026-01-28"
    }
  },
  "productid": "50090-3229_504c5166-e2ca-4a75-bb6a-02798584ca64",
  "productndc": "50090-3229",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "072695",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nortrel",
  "active_ingred_unit": null,
  "application_number": "ANDA072695",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
  "start_marketing_date": "20010606",
  "active_numerator_strength": null
}

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