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 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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 2026-08-01
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