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United States · US · US:63629-2336_8abd054d-ac7b-442a-9b09-01e349d336df

LORYNA

Orange BookSPL

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362923361
    3 CARTON in 1 CARTON (63629-2336-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A079221
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "ed92658d-87e3-4b5a-912f-0b51943da5e3": {
      "match": "brand_token",
      "title": "LORYNA (DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS) KIT [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2024-01-12"
    }
  },
  "productid": "63629-2336_8abd054d-ac7b-442a-9b09-01e349d336df",
  "productndc": "63629-2336",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "079221",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG;0.02MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LORYNA",
  "active_ingred_unit": null,
  "application_number": "ANDA079221",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Drospirenone and Ethinyl Estradiol Tablets",
  "start_marketing_date": "20181009",
  "active_numerator_strength": null
}

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