12658-0634 NDC - ABEMACICLIB

Drug Information

  • Product NDC: 12658-0634
  • Proprietary Name:
  • Non Proprietary Name: ABEMACICLIB
  • Active Ingredient(s): 1 kg/kg ABEMACICLIB
  • Administration Route(s):
  • Dosage Form(s): POWDER

Labeler Information

Field Name Field Value
Labeler Name: Pharmaceutical Works POLPHARMA
Product Type: BULK INGREDIENT
FDA Application Number:
Marketing Category: BULK INGREDIENT
Start Marketing Date:9/28/2017

Package Information

No. Package Code Package Description Billing Unit
112658-0634-11 kg in 1 DRUM (12658-0634-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC12658-0634The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEBULK INGREDIENTIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAMEABEMACICLIBThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThis 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 DATE9/28/2017Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEBULK INGREDIENTProduct 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.
LABELER NAMEPharmaceutical Works POLPHARMAName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEABEMACICLIBAn 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.
ACTIVE NUMERATOR STRENGTH1 
ACTIVE INGRED UNITkg/kg 

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

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