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United States · US · US:0093-6031_829171b9-7397-4809-a8cf-8f3073917701

Rivelsa

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    0093603182
    2 POUCH in 1 CARTON (0093-6031-82) / 1 KIT in 1 POUCH (0093-6031-91)

Annotations

Orange Book
N204061
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "822e56c6-562f-4299-bf4f-eaee0c0f2b7a": {
      "match": "brand_token",
      "title": "RIVELSA (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "13",
      "published_date": "2024-10-28"
    }
  },
  "productid": "0093-6031_829171b9-7397-4809-a8cf-8f3073917701",
  "productndc": "0093-6031",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204061",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A",
        "product_no": "001",
        "approval_date": "Mar 28, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Rivelsa",
  "active_ingred_unit": null,
  "application_number": "NDA204061",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20170403",
  "active_numerator_strength": null
}

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