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NDC 00078-0860-01 KISQALI 200 mg/1 Details
KISQALI 200 mg/1
KISQALI is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is RIBOCICLIB SUCCINATE.
MedlinePlus Drug Summary
Ribociclib is used in combination with another medication to treat a certain type of hormone receptor–positive (depends on hormones such as estrogen to grow) advanced breast cancer or that has spread to other parts of the body in women who have not experienced menopause (change of life; end of monthly menstrual periods) and in those who are close to or who have already experienced menopause. Ribociclib is also used in combination with fulvestrant (Faslodex) to treat a certain type of hormone receptor–positive advanced breast cancer or that has spread to other parts of the body as an initial treatment or in people who have not been treated successfully with other treatments in women who have already experienced menopause. Ribociclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
Related Packages: 00078-0860-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ribociclib
Product Information
| NDC | 00078-0860 |
|---|---|
| Product ID | 0078-0860_0916c545-7f68-439d-86f8-66b166eab6d0 |
| Associated GPIs | 2153107050B720 |
| GCN Sequence Number | 077216 |
| GCN Sequence Number Description | ribociclib succinate TABLET 200 MG/DAY ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 43162 |
| HICL Sequence Number | 044151 |
| HICL Sequence Number Description | RIBOCICLIB SUCCINATE |
| Brand/Generic | Brand |
| Proprietary Name | KISQALI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ribociclib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | RIBOCICLIB SUCCINATE |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209092 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0860-01 (00078086001)
| NDC Package Code | 0078-0860-01 |
|---|---|
| Billing NDC | 00078086001 |
| Package | 1 BLISTER PACK in 1 CARTON (0078-0860-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-03-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |