Back to search
🇺🇸

United States · US · US:0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150

Sprintec

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
    0555901658
    6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A075804
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "90240210-0bca-4a55-99dc-19f2b40d8e3f": {
      "match": "brand_token",
      "title": "SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PREFERRED PHARMACEUTICALS, INC.]",
      "spl_version": "8",
      "published_date": "2025-09-29"
    }
  },
  "productid": "0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150",
  "productndc": "0555-9016",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075804",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "Sep 25, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Sprintec",
  "active_ingred_unit": null,
  "application_number": "ANDA075804",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
  "start_marketing_date": "20020926",
  "active_numerator_strength": null
}

Access this data programmatically

Query Sprintec and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.