rebinyn

Generic: coagulation factor ix recombinant, glycopegylated

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name rebinyn
Generic Name coagulation factor ix recombinant, glycopegylated
Labeler novo nordisk
Dosage Form KIT
Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-7905
Product ID 0169-7905_4d658384-07d9-471f-8b15-16b8cec36765
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125611
Listing Expiration 2026-12-31
Marketing Start 2017-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01697905
Hyphenated Format 0169-7905

Supplemental Identifiers

RxCUI
1990857 1990862

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 rebinyn (source: ndc)
Generic Name coagulation factor ix recombinant, glycopegylated (source: ndc)
Application Number BLA125611 (source: ndc)

Resolved Composition

Strengths
  • 3000 iu
  • 4 ml
  • 750 iu/ml
  • 1.6 mg/ml
source: label
Packaging
  • 1 KIT in 1 KIT (0169-7905-01) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11)
  • 1 KIT in 1 KIT (0169-7905-97) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11)
source: ndc

Packages (2)

0169-7905-01 1 KIT in 1 KIT (0169-7905-01) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11) 0169-7905-97 1 KIT in 1 KIT (0169-7905-97) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

REBINYN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "4d658384-07d9-471f-8b15-16b8cec36765", "openfda": {"rxcui": ["1990857", "1990862"], "spl_set_id": ["0ea37235-35fd-410d-b8c4-40ba15fe1294"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (0169-7905-01)  *  4 mL in 1 VIAL, GLASS (0169-7955-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7955-11)", "package_ndc": "0169-7905-01", "marketing_start_date": "20171201"}, {"sample": true, "description": "1 KIT in 1 KIT (0169-7905-97)  *  4 mL in 1 VIAL, GLASS (0169-7955-90)  *  4 mL in 1 SYRINGE, GLASS (0169-7009-98)  *  4 mL in 1 VIAL, GLASS (0169-7955-11)", "package_ndc": "0169-7905-97", "marketing_start_date": "20220505"}], "brand_name": "REBINYN", "product_id": "0169-7905_4d658384-07d9-471f-8b15-16b8cec36765", "dosage_form": "KIT", "product_ndc": "0169-7905", "generic_name": "coagulation factor IX recombinant, GlycoPEGylated", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "REBINYN", "application_number": "BLA125611", "marketing_category": "BLA", "marketing_start_date": "20171201", "listing_expiration_date": "20261231"}