KISQALI FEMARA CO-PACK

Orange BookSPL

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078090961
1 KIT in 1 KIT (0078-0909-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0888-21)

Annotations

Orange Book

N209935

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "aaeaef94-f3f5-4367-8ea2-b181d7be2da8": {
      "match": "brand_token",
      "title": "KISQALI (RIBOCICLIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "27",
      "published_date": "2025-12-16"
    }
  },
  "productid": "0078-0909_774105bc-8258-481c-8883-f25f25166aea",
  "productndc": "0078-0909",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "209935",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG;EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "May 4, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "KISQALI FEMARA CO-PACK",
  "active_ingred_unit": null,
  "application_number": "NDA209935",
  "marketing_category": "NDA",
  "nonproprietary_name": "letrozole and ribociclib",
  "start_marketing_date": "20170504",
  "active_numerator_strength": null
}

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