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United States · US · US:68180-846_9d52f9d2-f66b-4457-8cb7-c48a6e7d076f

Daysee

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    6818084613
    2 POUCH in 1 CARTON (68180-846-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A091467
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "a9861412-4e54-4984-b14c-a1dd91d5c946": {
      "match": "brand_token",
      "title": "DAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "17",
      "published_date": "2025-05-15"
    }
  },
  "productid": "68180-846_9d52f9d2-f66b-4457-8cb7-c48a6e7d076f",
  "productndc": "68180-846",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091467",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG,0.01MG;0.15MG,N/A",
        "product_no": "001",
        "approval_date": "Apr 10, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Daysee",
  "active_ingred_unit": null,
  "application_number": "ANDA091467",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVONORGESTREL AND ETHINYL ESTRADIOL",
  "start_marketing_date": "20130410",
  "active_numerator_strength": null
}

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