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United States · US · US:68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7

Ashlyna

Orange BookSPL

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846264693
    2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91)

Annotations

Orange Book
A203163
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "407a9f63-9abf-4886-864a-d3dd0e429762": {
      "match": "brand_token",
      "title": "ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "10",
      "published_date": "2026-01-30"
    }
  },
  "productid": "68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7",
  "productndc": "68462-646",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203163",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG,0.01MG;0.15MG,N/A",
        "product_no": "001",
        "approval_date": "Feb 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Ashlyna",
  "active_ingred_unit": null,
  "application_number": "ANDA203163",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20150223",
  "active_numerator_strength": null
}

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