FDA.reportPublic FDA data

NDC 0300-3612-28 - Lupron

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
0300-3612
Requested NDC
0300-3612-28
Package NDCs from labels
0300-3612-28, 0300-3612-24
Manufacturer
TAP Pharmaceutical Products Inc.
Effective date
2008-02-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LUPRON ® INJECTION (leuprolide acetate)TAP Pharmaceutical Products Inc.2008-02-29HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0300-3612-24Lupron6 in 1 CARTONINJECTION, SOLUTION61
0300-3612-24Lupron1 in 1 CARTONINJECTION, SOLUTION11
0300-3612-28Lupron2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL1
0300-3612-28Lupron1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0300-3612LUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]14 package rows20080325_319F0AF7-6CC7-4A91-A28A-9CEEA37D0CA8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
leuprolide acetateACTIVE INGREDIENT37JNS02E7VLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
leuprolideACTIVE MOIETYEFY6W0M8TGLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
acetic acidINACTIVE INGREDIENTQ40Q9N063PLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
acetic acid,INACTIVE INGREDIENTLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLUPRON (LEUPROLIDE ACETATE) LUPRON (LEUPROLIDE ACETATE) INJECTION, SOLUTION [TAP PHARMACEUTICAL PRODUCTS INC.]1

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

Reported adverse events (FAERS/openFDA)#

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