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United States · US · US:70748-322_5b904f9d-2551-48bd-8945-d464ea5094c5

MINZOYA

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    7074832214
    3 BLISTER PACK in 1 CARTON (70748-322-14) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A217087
AB3
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "d5ebd7fa-c388-4619-8dcb-e862e4ce5285": {
      "match": "brand_token",
      "title": "MINZOYA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS BISGLYCINATE) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-01-23"
    }
  },
  "productid": "70748-322_5b904f9d-2551-48bd-8945-d464ea5094c5",
  "productndc": "70748-322",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "217087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Feb 15, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "MINZOYA",
  "active_ingred_unit": null,
  "application_number": "ANDA217087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol and ferrous bisglycinate",
  "start_marketing_date": "20250109",
  "active_numerator_strength": null
}

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