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United States · US · US:51862-868_f0f0ade0-5eb1-45a7-b07f-8c86d8ecf548

Microgestin 1/20

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
    5186286801
    1 BLISTER PACK in 1 PACKET (51862-868-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186286802
    1 BLISTER PACK in 1 CARTON (51862-868-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5186286803
    3 BLISTER PACK in 1 CARTON (51862-868-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A202995
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "0a372f10-41ac-4953-a2d5-a913672b3b21": {
      "match": "brand_token",
      "title": "MICROGESTIN 1/20 ( NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "51862-868_f0f0ade0-5eb1-45a7-b07f-8c86d8ecf548",
  "productndc": "51862-868",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202995",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Microgestin 1/20",
  "active_ingred_unit": null,
  "application_number": "ANDA202995",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate/Ethinyl Estradiol",
  "start_marketing_date": "20201012",
  "active_numerator_strength": null
}

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