What is KISQALI used for and KISQALI Product NDC number? Below is the most updated information on the Product NDC number 0078-0860 – KISQALI drug (ribociclib). Medical Code Data provides all information of this drug products including NDC product code, labeler name, dosage form & certification date.
What is KISQALI?
KISQALI is a HUMAN PRESCRIPTION DRUG labeled by Novartis Pharmaceuticals Corporation. KISQALI, commonly known as ribociclib, is assigned Product NDC number 0078-0860. KISQALI is marketed under the NDA category with application number NDA209092. KISQALI‘s dosage form is TABLET, FILM COATED and is administered via ORAL form.
- Proprietary Name / Trade Name: KISQALI
- Non Proprietary Name / Generic Name: ribociclib
- Product Type Name: HUMAN PRESCRIPTION DRUG
- Proprietary Name Suffix:
Uses & dosage information
- Dosage Form Name: TABLET, FILM COATED
- Route Name: ORAL
- Substance Name: RIBOCICLIB
- Active strength Number: 200
- Active Strength Unit: mg/1
- Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
What is KISQALI used for? We are updating more information on uses, dosage, side effects, warnings, reviews and pictures of KISQALI (generic name KISQALI) – Product NDC number 0078-0860 . Please visit MedCodeData.com frequently to get the most updated information
- Marketing Category Name: NDA
- Labeler Name: Novartis Pharmaceuticals Corporation
- NDC Exclude Flag: N
- FDA Public: Approved (Please Visit FDA for latest update)
- Product ID: 0078-0860_45dd3300-d8f2-462a-8564-4b063a584f23
- Product NDC Number: 0078-0860
- Application Number: NDA209092
- Start Marketing Date: 2017-03-13
- End Marketing Date:–
- Listing Record Certified Through: 2019-12-31
Above are up-to-date information of KISQALI – 0078-0860. There are no other drug products that have the same NDC identifier number. You can lookup more NDC number by clicking here
Useful information of the NDC Directory by FDA
What is NDC?
NDC (stands for National Drug Code) is a universal product identifier for human drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the United States. An NDC number for a specific drug is created by the the FDA and the manufacturer to ensure that products can be differentiated. The NDC database includes all information submitted to the FDA as part of drug listing requirements under section 510 of the FD&C Act, 21 USC 360.
How is the NDC formatted?
An NDC number contains 3 segments: the labeler code (identifies the manufacturer, repackager or distributor), the product code (identifies a specific strength, dosage form, and formulation) and the package code (identifies package types and sizes).
Important notes regarding NDC
- Assignment of an NDC number does not in any way denote FDA approval of the product.
- Assignment of an NDC number does not denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
- National Drug Code Directory does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients(APIs), drugs for further processing,…
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DISCLAIMER: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.