NDC 0078-0867
KISQALI
Ribociclib
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.
| Product ID | 0078-0867_0ef16a12-43a8-4956-b1c1-07877366d919 |
| NDC | 0078-0867 |
| Product Type | Human Prescription Drug |
| Proprietary Name | KISQALI |
| Generic Name | Ribociclib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-03-13 |
| Marketing Category | NDA / NDA |
| Application Number | NDA209092 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | RIBOCICLIB |
| Active Ingredient Strength | 200 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0078-0867-42
3 BLISTER PACK in 1 CARTON (0078-0867-42) > 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)
| Marketing Start Date | 2017-03-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0078-0867-14 [00078086714]
KISQALI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209092 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-13 |
NDC 0078-0867-42 [00078086742]
KISQALI TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209092 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-03-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RIBOCICLIB | 200 mg/1 |
OpenFDA Data
| SPL SET ID: | aaeaef94-f3f5-4367-8ea2-b181d7be2da8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Kinase Inhibitors [MoA]
- Cytochrome P450 3A Inhibitors [MoA]
NDC Crossover Matching brand name "KISQALI" or generic name "Ribociclib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0860 | KISQALI | ribociclib |
| 0078-0867 | KISQALI | ribociclib |
| 0078-0874 | KISQALI | ribociclib |
Trademark Results [KISQALI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KISQALI 79156360 4820261 Live/Registered |
NOVARTIS AG 2014-10-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.