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 156 of 177 · 3,533 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen PeroxideHYDROGEN PEROXIDE 3.0%Trifecta Pharmaceuticals USA, LLC.e4e45f11-7cd4-e693-e053-2a95a90a4c342024-01-02WarningsExact identifier
application number: M003
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.27ba0f30-e066-f240-e063-6394a90ae7cb2024-01-01WarningsExact identifier
application number: M003
Freskaro Decolorized IodineALCOHOLPharma Nobis, LLCfbd222a2-1151-99b9-e053-6394a90a8bb82023-12-28WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLTopco Associates65270825-48b1-49e7-a14e-f73df9beb9dd2023-12-27WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Humco Hydrogen PeroxideHYDROGEN PEROXIDE 3%Pharma Nobis, LLCe42f876d-0477-c4d5-e053-2a95a90ae6d42023-12-26WarningsExact identifier
application number: M003
Ear Drops for SwimmersISOPROPYL ALCOHOLPharma Nobis, LLCe42fd693-24ab-0fc0-e053-2995a90ab9542023-12-26WarningsExact identifier
unii: ND2M416302
Ethyl Rubbing Alcohol 70 PercentETHYL ALCOHOLPharma Nobis, LLCe42fccc2-1b50-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M003
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
application number: M003
unii: ND2M416302
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
CVS MerthiolateBENZALKONIUM CHLORIDECVS Pharmacydd498ab1-8350-41aa-86fc-2db57005f3e22023-12-22WarningsExact identifier
application number: M003
LEADER Ear Drops for SwimmersLEADER EAR DROPS FOR SWIMMERSCardinal Health, 110 dba Leader874857eb-2a9d-6ef7-e053-2995a90af1562023-12-22WarningsExact identifier
unii: ND2M416302
Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLCe42eee1b-3539-fb17-e053-2995a90af61d2023-12-22WarningsExact identifier
application number: M003
Decolorized IodineETHYL ALCOHOLPharma Nobis, LLCe21dd43b-3712-cb16-e053-2a95a90ac2762023-12-22WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f727c-beb0-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
unii: ND2M416302
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Pharma Nobis, LLCe42ee827-b350-7b56-e053-2a95a90a69cf2023-12-22WarningsExact identifier
application number: M003
MerthiolateBENZALKONIUM CHLORIDEPharma Nobis, LLCe42f727c-beaf-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M003
unii: ND2M416302
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
unii: ND2M416302
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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