Cryselle

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
5009021830
1 KIT in 1 KIT (50090-2183-0)

Annotations

Orange Book

A075840

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "f73ece43-6b5f-4abb-ba6d-4d62775f2f8e": {
      "match": "brand_token",
      "title": "CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-03-05"
    }
  },
  "productid": "50090-2183_cbabd0f6-72ca-4dd5-8b3f-9f1ad7c41c2f",
  "productndc": "50090-2183",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075840",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.3MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.3MG",
        "product_no": "002",
        "approval_date": "Nov 30, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cryselle",
  "active_ingred_unit": null,
  "application_number": "ANDA075840",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20020724",
  "active_numerator_strength": null
}

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