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 59137-289
Product ID 59137-289_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 59137289
Hyphenated Format 59137-289

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
  • 1 KIT in 1 CARTON (59137-289-05) * 5 mL in 1 VIAL (59137-277-01) * 5 mL in 1 SYRINGE (59137-280-01)
source: ndc

Packages (1)

59137-289-05 1 KIT in 1 CARTON (59137-289-05) * 5 mL in 1 VIAL (59137-277-01) * 5 mL in 1 SYRINGE (59137-280-01)

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": [{"sample": false, "description": "1 KIT in 1 CARTON (59137-289-05)  *  5 mL in 1 VIAL (59137-277-01)  *  5 mL in 1 SYRINGE (59137-280-01)", "package_ndc": "59137-289-05", "marketing_start_date": "20210701"}], "brand_name": "Ixinity", "product_id": "59137-289_5e2b1242-2977-463b-ac2c-f89dadfba407", "dosage_form": "KIT", "product_ndc": "59137-289", "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"}