Drug Information

Product NDC: 0597-0197

Proprietary Name: Praxbind

Non Proprietary Name: idarucizumab

Active Ingredient(s):

Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION

Pharmacy Class(es):
  • Humanized Monoclonal Antibody Fragment [EPC];
  • Antibodies;
  • Monoclonal;
  • Humanized [CS]

Labeler Information

Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
FDA Application Number: BLA761025
Marketing Category: BLA
Start Marketing Date:10/21/2015

Package Information

No. Package Code Package Description Billing Unit
10597-0197-052 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) > 50 mL in 1 VIAL, SINGLE-DOSE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0597-0197The 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 NAMEPraxbindThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEidarucizumabThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/21/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA761025This 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.
LABELER NAMEBoehringer Ingelheim Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIDARUCIZUMABThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESHumanized Monoclonal Antibody Fragment [EPC],Antibodies, Monoclonal, Humanized [CS] 

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This page was last updated on: 7/3/2020