Home NDC 59385-055-01 NDC 59385-055-01 - ELYXYB - celecoxib This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 59385-055
Requested NDC 59385-055-01
Package NDCs from labels 59385-055-01, 59385-055-06, 59385-055-02, 59385-055-22
Manufacturer BioDelivery Sciences International Inc
Effective date 2021-10-01
Current FDA listing Not matched in FDA.report NDC product tables FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59385-055-01 ELYXYB - celecoxib 4.8 mL in 1 BOTTLE LIQUID 4.8 1 59385-055-02 ELYXYB - celecoxib 4.8 mL in 1 BOTTLE LIQUID 4.8 1 59385-055-06 ELYXYB - celecoxib 6 in 1 CARTON LIQUID 6 1 59385-055-22 ELYXYB - celecoxib 1 in 1 CARTON LIQUID 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59385-055 ELYXYB - CELECOXIB (CELECOXIB) LIQUID [BIODELIVERY SCIENCES INTERNATIONAL INC] 1 Legacy NDC, 4 package rows 20220101_a0bfcba9-0af6-4b45-80e3-c4c94065b777.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 13 of 166 · 3,301 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.