Home NDC 50090-4534 HYLENEX Recombinant
Product NDC 50090-4534
11-digit product format 500904534
Labeler code 50090
Product ID 50090-4534_022f7985-c63d-40b2-941b-760a1590ee9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyaluronidase (Human Recombinant)
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler A-S Medication Solutions
Application BLA021859
Marketing category BLA
Marketing start 2005-12-02
Marketing end 0000-00-00
Substance HYALURONIDASE (HUMAN RECOMBINANT)
Active strength 150 [USP'U]/mL
Pharmacologic classes Endoglycosidase [EPC],Glycoside Hydrolases [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 50090-4534 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-4534 50090-4534-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-4534-0 2023-02-07 C162847 48780-1 f386c64a-444a-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005 50090-4534-0 2023-01-30 C162847 48780-1 f386c64a-444a-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4534 HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] 9 Legacy NDC 20230208_75f75f29-e369-449d-aa46-179ae02d1fe9.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 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021859 Hylenex recombinant hyaluronidase human 351(a) Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-4534-0 50090453400 1 mL in 1 VIAL (50090-4534-0) 1 ml 2019-09-18 0000-00-00 No No Current