Tri-Sprintec

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
0555901858
6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A075808

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "1f8b9aad-f31f-4cda-861d-c08a977fc923": {
      "match": "brand_token",
      "title": "TRI-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "8",
      "published_date": "2025-10-03"
    }
  },
  "productid": "0555-9018_6aba763f-7cd9-4e4d-96f0-36109b8efa73",
  "productndc": "0555-9018",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075808",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Dec 29, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Tri-Sprintec",
  "active_ingred_unit": null,
  "application_number": "ANDA075808",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20031229",
  "active_numerator_strength": null
}

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