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United States · US · US:65862-865_e44389c6-fdd2-408e-8bfe-324842c36d76

Iclevia

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6586286583
    3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A206850
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "00657f4e-9df8-4f58-91a0-eff5a467f988": {
      "match": "brand_token",
      "title": "ICLEVIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "9",
      "published_date": "2024-08-05"
    }
  },
  "productid": "65862-865_e44389c6-fdd2-408e-8bfe-324842c36d76",
  "productndc": "65862-865",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206850",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Jun 29, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Iclevia",
  "active_ingred_unit": null,
  "application_number": "ANDA206850",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20180629",
  "active_numerator_strength": null
}

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