Portia

Orange BookSPL

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

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
0555902058
6 POUCH in 1 CARTON (0555-9020-58) / 1 BLISTER PACK in 1 POUCH (0555-9020-79) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A075866

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "c78b236b-85c4-4258-a524-cea08775100c": {
      "match": "brand_token",
      "title": "PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "15",
      "published_date": "2025-04-10"
    }
  },
  "productid": "0555-9020_4d63fa4a-ff46-4f2e-b9d5-cab4f5fe1d85",
  "productndc": "0555-9020",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075866",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "May 23, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "002",
        "approval_date": "May 23, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Portia",
  "active_ingred_unit": null,
  "application_number": "ANDA075866",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20020627",
  "active_numerator_strength": null
}

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