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United States · US · US:63187-911_cf674be7-f206-4b82-ab29-e9658b7f70a6

Sprintec

Orange BookSPL

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

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
    6318791128
    1 BLISTER PACK in 1 POUCH (63187-911-28) / 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": "63187-911_cf674be7-f206-4b82-ab29-e9658b7f70a6",
  "productndc": "63187-911",
  "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
}

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