TRI-LO-MARZIA

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
6318775428
1 BLISTER PACK in 1 POUCH (63187-754-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A200541

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "bc402baa-5de4-4149-9857-081a9b4eb280": {
      "match": "brand_token",
      "title": "TRI-LO-MARZIA ( NORGESTIMATE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2025-12-11"
    }
  },
  "productid": "63187-754_3ef2edb0-29cc-45da-a3ef-c82f015b7ecb",
  "productndc": "63187-754",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Jun 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "TRI-LO-MARZIA",
  "active_ingred_unit": null,
  "application_number": "ANDA200541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20160118",
  "active_numerator_strength": null
}

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