praxbind

Generic: idarucizumab

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name praxbind
Generic Name idarucizumab
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

idarucizumab 50 mg/mL

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0197
Product ID 0597-0197_9474d542-4726-4546-a768-10d418cdf5cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761025
Listing Expiration 2026-12-31
Marketing Start 2015-10-21

Pharmacologic Class

Established (EPC)
humanized monoclonal antibody fragment [epc]
Chemical Structure
antibodies, monoclonal, humanized [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970197
Hyphenated Format 0597-0197

Supplemental Identifiers

RxCUI
1716195 1716200
UNII
97RWB5S1U6
NUI
N0000191873 M0556300

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name praxbind (source: ndc)
Generic Name idarucizumab (source: ndc)
Application Number BLA761025 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0597-0197-05 2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

idarucizumab (50 mg/mL)

Linked Drug Pages (1)

Praxbind ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9474d542-4726-4546-a768-10d418cdf5cc", "openfda": {"nui": ["N0000191873", "M0556300"], "unii": ["97RWB5S1U6"], "rxcui": ["1716195", "1716200"], "spl_set_id": ["c7400f8a-dcf4-a6df-6d07-983081b1bf34"], "pharm_class_cs": ["Antibodies, Monoclonal, Humanized [CS]"], "pharm_class_epc": ["Humanized Monoclonal Antibody Fragment [EPC]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0597-0197-05", "marketing_start_date": "20151021"}], "brand_name": "Praxbind", "product_id": "0597-0197_9474d542-4726-4546-a768-10d418cdf5cc", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal", "Humanized [CS]", "Humanized Monoclonal Antibody Fragment [EPC]"], "product_ndc": "0597-0197", "generic_name": "idarucizumab", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Praxbind", "active_ingredients": [{"name": "IDARUCIZUMAB", "strength": "50 mg/mL"}], "application_number": "BLA761025", "marketing_category": "BLA", "marketing_start_date": "20151021", "listing_expiration_date": "20261231"}