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United States · US · US:16714-365_cf47f8b4-e64e-4128-a197-54bcce596aa1

Elinest

Orange BookSPL

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

Identification

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

Packs · 4

  • ndc11
    1671436501
    1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671436502
    1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671436503
    3 BLISTER PACK in 1 CARTON (16714-365-03) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671436504
    6 BLISTER PACK in 1 CARTON (16714-365-04) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A091105
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "aa7f4a83-71cf-4306-b0a1-01784f67bae2": {
      "match": "brand_token",
      "title": "ELINEST (NORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
      "spl_version": "7",
      "published_date": "2025-12-10"
    }
  },
  "productid": "16714-365_cf47f8b4-e64e-4128-a197-54bcce596aa1",
  "productndc": "16714-365",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091105",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.3MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Elinest",
  "active_ingred_unit": null,
  "application_number": "ANDA091105",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20120107",
  "active_numerator_strength": null
}

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