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United States · US · US:50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8e

XULANE

In shortageOrange BookUNIISPLATC G03CA

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009016830
    3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCH

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A200910
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Etonogestrel Ring
Raw payload (JSON)
{
  "unii": {
    "unii": "423D2T571U",
    "rxcui": "4124",
    "inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
    "display_name": "ETHINYL ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "adcf17ef-e60b-48a4-9478-3998dab2bbbd": {
      "match": "brand_token",
      "title": "XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [A-S MEDICATION SOLUTIONS]",
      "spl_version": "15",
      "published_date": "2024-02-29"
    }
  },
  "productid": "50090-1683_ebc72113-be27-4819-9f7d-3ba574452d8e",
  "productndc": "50090-1683",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "200910",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG/24HR;0.15MG/24HR",
        "product_no": "001",
        "approval_date": "Apr 16, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; NORELGESTROMIN",
  "shortage_reason": "Ethinyl Estradiol; Etonogestrel Ring",
  "shortage_status": "current",
  "proprietary_name": "XULANE",
  "active_ingred_unit": "ug/d; ug/d",
  "application_number": "ANDA200910",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norelgestromin and ethinyl estradiol",
  "start_marketing_date": "20140416",
  "active_numerator_strength": "35; 150"
}

Related drugs

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