FDA.reportPublic FDA data

NDC 55150-338 - LEUPROLIDE ACETATE

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
55150-338
Package NDCs from labels
55150-338-01
Manufacturer
Eugia US LLC | EUGIA Pharma Specialities Limited
Effective date
2026-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEUPROLIDE ACETATE - Eugia US LLC | EUGIA Pharma Specialities LimitedEugia US LLC | EUGIA Pharma Specialities Limited2026-05-08Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-338-01LEUPROLIDE ACETATE1 in 1 CARTONINJECTION, SOLUTION1 mg in 0.2mL6
55150-338-01LEUPROLIDE ACETATE2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL1 mg in 0.2mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-338LEUPROLIDE ACETATE KIT [EUGIA US LLC]3Unmatched20241228_49a1d0c1-304c-46f2-a780-bd940ae1ced0.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 115 of 179 · 3,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
unii: ND2M416302
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
unii: ND2M416302
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.