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United States · US · US:51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab

Nextstellis

Orange Book

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

Identification

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

Packs · 2

  • ndc11
    5186225800
    1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)
  • ndc11
    5186225801
    1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)

Annotations

Orange Book
N214154
Raw payload (JSON)
{
  "route": null,
  "productid": "51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab",
  "productndc": "51862-258",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214154",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3MG;14.2MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nextstellis",
  "active_ingred_unit": null,
  "application_number": "NDA214154",
  "marketing_category": "NDA",
  "nonproprietary_name": "drospirenone and estetrol",
  "start_marketing_date": "20210416",
  "active_numerator_strength": null
}

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