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United States · US · US:71205-685_5b684f8f-9610-4449-a213-f70bb4a04b8b

Nortrel 7/7/7

Orange BookSPL

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7120568528
    1 BLISTER PACK in 1 POUCH (71205-685-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A075478
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": "71205-685_5b684f8f-9610-4449-a213-f70bb4a04b8b",
  "productndc": "71205-685",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075478",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nortrel 7/7/7",
  "active_ingred_unit": null,
  "application_number": "ANDA075478",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
  "start_marketing_date": "20030102",
  "active_numerator_strength": null
}

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