Home NDC 0169-7901 REBINYN
Product NDC 0169-7901
11-digit product format 001697901
Labeler code 0169
Product ID 0169-7901_4d658384-07d9-471f-8b15-16b8cec36765
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name coagulation factor IX recombinant, GlycoPEGylated
Dosage form KIT
Labeler Novo Nordisk
Application BLA125611
Marketing category BLA
Marketing start 2017-12-01
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join REBINYN COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED Novo Nordisk 0ea37235-35fd-410d-b8c4-40ba15fe1294 2022-08-11 Warnings, Adverse reactions Exact identifier application number: BLA125611 ndc (product): 0169-7901
Additional Listing Data#
Finished product Yes
Brand name base REBINYN
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1990857 Internal RxNorm lookup 1990862 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0169-7901-01 REBINYN 1 in 1 KIT KIT 1 9 0169-7901-97 REBINYN 1 in 1 KIT KIT 1 9 0169-7911-11 REBINYN 4 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 4 mL 250 [iU] in 1mL 9 0169-7911-90 REBINYN 4 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 4 mL 250 [iU] in 1mL 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-7901 REBINYN (COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED) KIT [NOVO NORDISK] 9 Current NDC, Legacy NDC, 4 package rows 20240808_0ea37235-35fd-410d-b8c4-40ba15fe1294.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125611 Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0169-7901-01 00169790101 1 KIT in 1 KIT (0169-7901-01) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) 1 kit 2017-12-01 0000-00-00 No No Current 0169-7901-97 00169790197 1 KIT in 1 KIT (0169-7901-97) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11) 1 kit 2022-05-05 0000-00-00 Yes No Current 0169-7911-11 00169791111 4 mL in 1 VIAL, GLASS 4 ml Historical 0169-7911-90 00169791190 4 mL in 1 VIAL, GLASS 4 ml Historical