57962-014 NDC - IMBRUVICA (IBRUTINIB)

Drug Information

  • Product NDC: 57962-014
  • Proprietary Name: Imbruvica
  • Non Proprietary Name: Ibrutinib
  • Active Ingredient(s): 140 mg/1 IBRUTINIB
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Pharmacyclics LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA210563
Marketing Category: NDA
Start Marketing Date:2/16/2018

Package Information

No. Package Code Package Description Billing Unit
157962-014-281 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC57962-014The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEImbruvicaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIbrutinibThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/16/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAIndicates 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.
APPLICATION NUMBERNDA210563The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
LABELER NAMEPharmacyclics LLCThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
SUBSTANCE NAMEIBRUTINIBThe translation of the dosage form Code submitted by the firm.
ACTIVE NUMERATOR STRENGTH140 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] 

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This page was last updated on: 2/21/2026

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