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United States · US · US:51862-892_61a14c7a-159a-4856-b564-a97aee2bec6e

Necon

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 · 3

  • ndc11
    5186289201
    1 BLISTER PACK in 1 PACKET (51862-892-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186289202
    1 BLISTER PACK in 1 CARTON (51862-892-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186289206
    6 BLISTER PACK in 1 CARTON (51862-892-06) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A091204
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "e80714f4-cdfe-4d60-a4e1-b8c7b184cc46": {
      "match": "brand_token",
      "title": "NECON ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [MAYNE PHARMA INC.]",
      "spl_version": "2",
      "published_date": "2025-09-11"
    }
  },
  "productid": "51862-892_61a14c7a-159a-4856-b564-a97aee2bec6e",
  "productndc": "51862-892",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091204",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.5MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Necon",
  "active_ingred_unit": null,
  "application_number": "ANDA091204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol",
  "start_marketing_date": "20201012",
  "active_numerator_strength": null
}

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