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United States · US · US:75854-604_3bc4c615-77f6-47b5-af57-ebefeed6cca9

AVERI

Orange BookSPL

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

Identification

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

Packs · 2

  • ndc11
    7585460401
    1 BLISTER PACK in 1 CARTON (75854-604-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    7585460403
    3 BLISTER PACK in 1 CARTON (75854-604-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A218933
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "91359e20-0de1-4995-b525-58b7544e34dc": {
      "match": "brand_token",
      "title": "AVERI (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS, LLC]",
      "spl_version": "2",
      "published_date": "2025-06-09"
    }
  },
  "productid": "75854-604_3bc4c615-77f6-47b5-af57-ebefeed6cca9",
  "productndc": "75854-604",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218933",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG;0.03MG",
        "product_no": "001",
        "approval_date": "May 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG;0.03MG",
        "product_no": "002",
        "approval_date": "May 2, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "AVERI",
  "active_ingred_unit": null,
  "application_number": "ANDA218933",
  "marketing_category": "ANDA",
  "nonproprietary_name": "desogestrel and ethinyl estradiol",
  "start_marketing_date": "20250605",
  "active_numerator_strength": null
}

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