Home NDC 87754-0003 Spirudio
Product NDC 87754-0003
11-digit product format 877540003
Labeler code 87754
Product ID 87754-0003_537294e5-3647-7e41-e063-6294a90a145a
Type HUMAN OTC DRUG
Nonproprietary name Spirudio
Dosage form TABLET
Route SUBLINGUAL
Labeler PROGRESYVUS TYRIMAI MB
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-06-01
Substance LAPINE S-100 IMMUNE GLOBULIN
Active strength 200 [hp_C]/U
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Spirudio
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAPINE S-100 IMMUNE GLOBULIN 200 [hp_C]/U
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A4FH976KAQ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87754-0003-1 87754000301 60 U in 1 BOTTLE (87754-0003-1) 60 u 2026-06-01 No No Current