ixinity

Generic: coagulation factor ix (recombinant)

Labeler: medexus pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ixinity
Generic Name coagulation factor ix (recombinant)
Labeler medexus pharma, inc.
Dosage Form KIT
Manufacturer
Medexus Pharma, Inc.

Identifiers & Regulatory

Product NDC 59137-287
Product ID 59137-287_5e2b1242-2977-463b-ac2c-f89dadfba407
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125426
Listing Expiration 2026-12-31
Marketing Start 2017-05-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59137287
Hyphenated Format 59137-287

Supplemental Identifiers

RxCUI
1666311 1666328
UPC
0059137275010 0059137272019 0059137271012 0059137270015 0059137276017 0359137280015 0059137277014

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 ixinity (source: ndc)
Generic Name coagulation factor ix (recombinant) (source: ndc)
Application Number BLA125426 (source: ndc)

Resolved Composition

Strengths
  • 3000 iu
  • 10 ml
  • 5 ml
  • 250 iu
  • 500 iu
  • 1000 iu
  • 1500 iu
  • 2000 iu
source: label
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING IXINITY is supplied as a lyophilized powder in single-dose glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). The actual factor IX activity in IU is stated on the label of each vial. Kits include one single-dose vial (containing nominally 250, 500, 1000, 1500, 2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod attached, and a vial adapter with filter. None of the kit components are made with natural rubber latex. Color Code Nominal Strength Kit NDC Number Yellow 250 IU 59137-287-05 Blue 500 IU 59137-282-05 Green 1000 IU 59137-283-05 Orange 1500 IU 59137-284-05 Red 2000 IU 59137-288-05 Brown 3000 IU 59137-289-05 250 IU strength only; store at 2 to 8°C (36 to 46°F). 500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to 77°F). Do not freeze. Keep the vial in the carton and protect from light. Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution. Do not refrigerate after reconstitution.
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-275-01 - 250 IU Single-Use Vial Label 250 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-287-05 - 250 IU Kit Carton 250 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-270-01 - 500 IU Single-Use Vial Label 500 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-282-05 - 500 IU Kit Carton 500 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-271-01 - 1000 IU Single-Use Vial Label 1000 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-283-05 - 1000 IU Kit Carton 1000 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-272-01 - 1500 IU Single-Use Vial Label 1500 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-284-05 - 1500 IU Kit Carton 1500 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-276-01 - 2000 IU Single-Use Vial Label 2000 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-288-05 - 2000 IU Kit Carton 2000 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-277-01 - 3000 IU Single-Use Vial Label 3000 IU Single-Use Vial Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-289-05 - 3000 IU Kit Carton 3000 IU Kit Label
  • PRINCIPAL DISPLAY PANEL - NDC: 59137-280-01 - Water for Injection 5 mL Single-Use Syringe Label Water for Injection 5 mL Single-Use Syringe Label
source: label

Packages (0)

No package records.

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Ixinity ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "5e2b1242-2977-463b-ac2c-f89dadfba407", "openfda": {"upc": ["0059137275010", "0059137272019", "0059137271012", "0059137270015", "0059137276017", "0359137280015", "0059137277014"], "rxcui": ["1666311", "1666328"], "spl_set_id": ["26bc221d-c9bc-4aba-92f3-6c21acaaf194"], "manufacturer_name": ["Medexus Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Ixinity", "product_id": "59137-287_5e2b1242-2977-463b-ac2c-f89dadfba407", "dosage_form": "KIT", "product_ndc": "59137-287", "generic_name": "coagulation factor IX (recombinant)", "labeler_name": "Medexus Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ixinity", "application_number": "BLA125426", "marketing_category": "BLA", "marketing_start_date": "20170512", "listing_expiration_date": "20261231"}