FDA.reportPublic FDA data

leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution

RxCUI
545835
RxNorm name
leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution
Display name
leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution
Full name
leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leuprolide acetateLEUPROLIDE ACETATEAmneal Pharmaceuticals LLC4838c674-044e-46b2-81e7-c691b99d8fa52026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 545835
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Pharmaceuticals USA Inc.35634415-000f-47db-9bd7-9e16eef3f02e2026-05-25Warnings, Adverse reactionsExact identifier
rxcui: 545835
Leuprolide AcetateLEUPROLIDE ACETATESandoz Inc8bd72c1e-2751-4498-a346-bc5e3acbba0b2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 545835
LEUPROLIDE ACETATELEUPROLIDE ACETATEEugia US LLC49a1d0c1-304c-46f2-a780-bd940ae1ced02026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 545835
leuprolide acetateLEUPROLIDE ACETATESun Pharmaceutical Industries, Inc.a3b01473-30c7-4945-bd60-2484221aaaad2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 545835
Leuprolide AcetateLEUPROLIDE ACETATEMeitheal Pharmaceuticals Incd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 545835
leuprolide acetateLEUPROLIDE ACETATEUBI Pharma Inc.cd46628f-055f-4da9-8c38-fa69af34eb4d2026-03-29Warnings, Adverse reactionsExact identifier
rxcui: 545835
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Lifesciences Limited4bae0e2a-dd36-4987-85ee-36a52e642ec72026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 545835
leuprolide acetateLEUPROLIDE ACETATEPAI Holdings, LLC dba PAI Pharma19be0b7f-e68a-4547-9e49-b51b128219072026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 545835
Leuprolide AcetateLEUPROLIDE ACETATEVGYAAN Pharmaceuticals LLCbec9077a-3f04-4887-856d-dde2de24584d2025-11-21Warnings, Adverse reactionsExact identifier
rxcui: 545835
Leuprolide AcetateLEUPROLIDE ACETATENorthStar RxLLC0cf31b40-816b-d055-e063-6294a90af5d02025-06-24Warnings, Adverse reactionsExact identifier
rxcui: 545835
LEUPROLIDE ACETATELEUPROLIDE ACETATEEndo USA, Inc.290b0716-2fd5-43a1-8d3c-4857c1b2eefa2024-06-10Warnings, Adverse reactionsExact identifier
rxcui: 545835

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 13 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8bd72c1e-2751-4498-a346-bc5e3acbba0bleuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]324Leuprolide Acetate Injection Rx Only20260519
a3b01473-30c7-4945-bd60-2484221aaaadleuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]318Leuprolide Acetate Injection Rx only20260424
4838c674-044e-46b2-81e7-c691b99d8fa5leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]39Leuprolide Acetate Injection [14 mg/2.8 mL (1 mg/0.2 mL)] Rx only20251217
bec9077a-3f04-4887-856d-dde2de24584dleuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]37Leuprolide Acetate Injection Rx only20251121
0cf31b40-816b-d055-e063-6294a90af5d0leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]37Leuprolide Acetate Injection Rx only20250624
35634415-000f-47db-9bd7-9e16eef3f02eleuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]36Leuprolide Acetate Injection Rx only20260525
49a1d0c1-304c-46f2-a780-bd940ae1ced0leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]36Leuprolide Acetate Injection Rx only20260508
cd46628f-055f-4da9-8c38-fa69af34eb4dleuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]36Leuprolide Acetate Injection (leuprolide acetate) Rx only20260329
19be0b7f-e68a-4547-9e49-b51b12821907leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]34Leuprolide Acetate Injection (leuprolide acetate) Rx only20260116
15003c37-6e91-4c79-a85c-3d03343b53f9leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]33Leuprolide Acetate Injection (leuprolide acetate) (For Subcutaneous Injection)20260413
4bae0e2a-dd36-4987-85ee-36a52e642ec7leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]33Leuprolide Acetate Injection Rx only20260209
d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]32Leuprolide Acetate Injection20250616
319f0af7-6cc7-4a91-a28a-9ceea37d0ca8leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution [PSN] · leuprolide acetate 5 MG/ML Injectable Solution [SCD] · leuprolide acetate 1 MG per 0.2 ML Injectable Solution [SY]31LUPRON ® INJECTION (leuprolide acetate)20080229