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 28 of 182 · 3,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic HandCHLOROXYLENOLImage Supply, Inc.7edd2630-bd0b-473f-85ab-34c74e8a3a0f2026-05-11WarningsExact identifier
application number: M003
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
ChemsepticCHLOROXYLENOLRochester Midland Corporationf3109c8d-c684-47a7-b26a-32e3ba64b8382026-05-11WarningsExact identifier
application number: M003
Lynx AntibacterialCHLOROXYLENOLABC Compounding Co., Inc.b469cfb7-35bf-419d-b1dc-95dcfad611f52026-05-11WarningsExact identifier
application number: M003
1012 AntimicrobialCHLOROXYLENOLABC Compounding Co., Inc.4dc6367c-5347-4a5c-b0d0-e93a4277a8492026-05-11WarningsExact identifier
application number: M003
Ban-AidCHLOROXYLENOLPro Chem, Inc.a251093c-77d1-4a2b-ba3d-e8768656cf6c2026-05-11WarningsExact identifier
application number: M003
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
application number: M003
Handtastic Foamy Mango Antiseptic Hand and Body WashCHLOROXYLENOLMomar Incorporateda0df742f-185c-4a7a-87f1-d22ff361e3b62026-05-11WarningsExact identifier
application number: M003
Suds High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLPro chem, Inc.00214c45-8453-49f5-b3e9-c3602fe96e202026-05-11WarningsExact identifier
application number: M003
Sani Foam Mango Antiseptic Hand and Body WashCHLOROXYLENOLDelta Foremost Chemical Corporationce1b2056-8553-4ac1-985f-9327de60a0c22026-05-11WarningsExact identifier
application number: M003
Hand Guard High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLWechem, Inc.00956253-e0e8-49b7-9015-671a14f8df732026-05-11WarningsExact identifier
application number: M003
Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876CHLOROXYLENOLABC Compounding Co., Inc.404a53ba-00dd-4952-9d58-4c46b9b45a562026-05-11WarningsExact identifier
application number: M003
caring mill Lavender Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.fcbb6b34-6f0e-4b82-8b3f-1d702d88079a2026-05-11WarningsExact identifier
rxcui: 797544
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEEugia US LLC49a1d0c1-304c-46f2-a780-bd940ae1ced02026-05-08Warnings, Adverse reactionsExact identifier
application number: ANDA212963
ndc (package): 55150-478-01
ndc (package): 60913-006-01
ndc (package): 55150-338-01
ndc (product): 55150-478
rxcui: 545835
rxcui: 797544
spl id: 25c69313-82c8-41fb-8bf5-13faf47519c5
spl set id: 49a1d0c1-304c-46f2-a780-bd940ae1ced0
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsExact identifier
application number: M003
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsExact identifier
application number: M003
Lucys Renewals Skin and Nails First Aid AntisepticBENZETHONIUM CHLORIDEACP Laboratories LLCa702297d-8f7e-4019-a987-7bd83becb5ee2026-05-07WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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