Apri

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
0555904358
6 POUCH in 1 CARTON (0555-9043-58) / 1 BLISTER PACK in 1 POUCH (0555-9043-79) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A075256

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "3448d121-d00a-4752-8782-416b7a376f3f": {
      "match": "brand_token",
      "title": "APRI 28 DAY (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]",
      "spl_version": "23",
      "published_date": "2024-06-21"
    }
  },
  "productid": "0555-9043_06176d8d-c9e2-4912-ab6d-ecb3d5e514d8",
  "productndc": "0555-9043",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG;0.03MG",
        "product_no": "001",
        "approval_date": "Aug 12, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG;0.03MG",
        "product_no": "002",
        "approval_date": "Aug 12, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Apri",
  "active_ingred_unit": null,
  "application_number": "ANDA075256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desogestrel and Ethinyl Estradiol",
  "start_marketing_date": "19991022",
  "active_numerator_strength": null
}

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