Aviane

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6318788928
1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A075796

AB1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "411e6e51-b435-4f86-b39f-3377f009b0e9": {
      "match": "brand_token",
      "title": "AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP]",
      "spl_version": "5",
      "published_date": "2024-10-24"
    }
  },
  "productid": "63187-889_8ba026e3-dc92-4a89-82db-923183c27184",
  "productndc": "63187-889",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.02MG;0.1MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Aviane",
  "active_ingred_unit": null,
  "application_number": "ANDA075796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20010402",
  "active_numerator_strength": null
}

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