SETLAKIN

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNorthstar Rx LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671436603
3 POUCH in 1 CARTON (16714-366-03) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A090716

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb": {
      "match": "brand_token",
      "title": "SETLAKIN (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
      "spl_version": "9",
      "published_date": "2025-12-10"
    }
  },
  "productid": "16714-366_f2cb2636-6eb7-4c73-add8-ebd8a18d158b",
  "productndc": "16714-366",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090716",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Sep 15, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "SETLAKIN",
  "active_ingred_unit": null,
  "application_number": "ANDA090716",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20150801",
  "active_numerator_strength": null
}

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