FDA.reportPublic FDA data

leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe

RxCUI
1115457
RxNorm name
leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe
Display name
leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe
Full name
leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.00c486b0-bd7b-4898-834d-8c656e5e73cb2025-09-18Warnings, Adverse reactionsExact identifier
rxcui: 1115457

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
00c486b0-bd7b-4898-834d-8c656e5e73cbleuprolide acetate 3.75 MG in 1 ML (1 month) Prefilled Syringe [PSN] · 1 ML leuprolide acetate 3.75 MG/ML Prefilled Syringe [SCD] · leuprolide acetate 3.75 MG per 1 ML (1 month) Prefilled Syringe [SY] · leuprolide acetate 3.75 MG per 1 ML Prefilled Syringe [SY]41478These highlights do not include all the information needed to use LUPRON DEPOT 3.75 mg safely and effectively. See full prescribing information for LUPRON DEPOT 3.75 mg. LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) for injection, for intramuscular use Initial U.S. Approval: 198520250918