MONO-LINYAH

Orange BookSPL

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009048810
1 KIT in 1 KIT (50090-4881-0)

Annotations

Orange Book

A090523

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "84a20017-344b-4684-a915-c85a55fcbbcb": {
      "match": "brand_token",
      "title": "MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
      "spl_version": "9",
      "published_date": "2025-03-27"
    }
  },
  "productid": "50090-4881_8f63aa7b-4463-4ac4-b9b2-7b608fb95bd2",
  "productndc": "50090-4881",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "May 23, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "MONO-LINYAH",
  "active_ingred_unit": null,
  "application_number": "ANDA090523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20120523",
  "active_numerator_strength": null
}

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