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United States · US · US:51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c

Zovia 1/35

Orange BookSPL

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

Identification

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

Packs · 2

  • ndc11
    5186289401
    1 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186289403
    3 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A209548
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "d0d2a9e9-e9ce-4a42-b429-5c1f9a544795": {
      "match": "brand_token",
      "title": "ZOVIA 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS) KIT [MAYNE PHARMA INC.]",
      "spl_version": "3",
      "published_date": "2025-11-17"
    }
  },
  "productid": "51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c",
  "productndc": "51862-894",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209548",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;1MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Zovia 1/35",
  "active_ingred_unit": null,
  "application_number": "ANDA209548",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ethynodiol Diacetate and Ethinyl Estradiol Tablets",
  "start_marketing_date": "20201016",
  "active_numerator_strength": null
}

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