17088-0163 NDC - ASCIMINIB

Drug Information

  • Product NDC: 17088-0163
  • Proprietary Name:
  • Non Proprietary Name: asciminib
  • Active Ingredient(s): 40 mg/1 ASCIMINIB HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s): TABLET, FILM COATED

Labeler Information

Field Name Field Value
Labeler Name: Novartis Pharma Stein AG
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:10/29/2021

Package Information

No. Package Code Package Description Billing Unit
117088-0163-125000 TABLET, FILM COATED in 1 DRUM (17088-0163-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC17088-0163The translation of the route code submitted by the firm, indicating route of administration.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEasciminibProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
DOSAGE FORM NAMETABLET, FILM COATEDThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE10/29/2021Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
LABELER NAMENovartis Pharma Stein AG 
SUBSTANCE NAMEASCIMINIB HYDROCHLORIDE 
ACTIVE NUMERATOR STRENGTH40 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 6/3/2026

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