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United States · US · US:68788-7429_9541df2a-fd96-47a1-a789-972e6b03366f

Sprintec

Orange BookSPL

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6878874292
    1 BLISTER PACK in 1 POUCH (68788-7429-2) / 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": "68788-7429_9541df2a-fd96-47a1-a789-972e6b03366f",
  "productndc": "68788-7429",
  "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": "20191001",
  "active_numerator_strength": null
}

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