FDA.reportPublic FDA data

NDC 0781-3006 - 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
0781-3006
Package NDCs from labels
0781-3006-42
Manufacturer
Sandoz Inc
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate - Sandoz IncSandoz Inc2026-05-19HUMAN PRESCRIPTION DRUG LABEL
Leuprolide Acetate - Bryant Ranch PrepackBryant Ranch Prepack2022-04-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3006-42Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL1 mg in 0.2mL24
0781-3006-42Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION1 mg in 0.2mL24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3006LEUPROLIDE ACETATE KIT [BRYANT RANCH PREPACK]101Unmatched20220428_19afe51a-3b2d-4286-ad32-992a34bba648.zip
0781-3006LEUPROLIDE ACETATE KIT [SANDOZ INC]21Unmatched20241204_8bd72c1e-2751-4498-a346-bc5e3acbba0b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302LEUPROLIDE ACETATE KIT [SANDOZ INC]13
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VLEUPROLIDE ACETATE KIT [SANDOZ INC]13
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302LEUPROLIDE ACETATE KIT [SANDOZ INC]13
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGLEUPROLIDE ACETATE KIT [SANDOZ INC]13
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PLEUPROLIDE ACETATE KIT [SANDOZ INC]13
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLEUPROLIDE ACETATE KIT [SANDOZ INC]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEUPROLIDE ACETATE KIT [SANDOZ INC]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEUPROLIDE ACETATE KIT [SANDOZ INC]13
WATERINACTIVE INGREDIENT059QF0KO0RLEUPROLIDE ACETATE KIT [SANDOZ INC]13

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 41 of 89 · 1,761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVR Alcohol Prep PadsISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffba233-6106-f633-e063-6394a90a96fe2025-09-29WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ProHeal Alcohol Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffc0619-eb13-77af-e063-6394a90a2fd92025-09-29WarningsExact identifier
rxcui: 797544
unii: ND2M416302
First Aid Direct Alcohol WipeISOPROPYL ALCOHOLCintas Corporation6a71449e-9a97-4923-8ec1-b1deb45b57462025-09-29WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Xpect Alcohol WipesALCOHOL WIPESCintas Corporation51185b9a-ed6b-4a49-b524-b3ff0d5c62902025-09-29WarningsExact identifier
unii: ND2M416302
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
FensolviLEUPROLIDE ACETATETOLMAR Inc.2c311700-edf4-4f2a-a468-9875489a6cc72025-09-25Warnings, Adverse reactionsExact identifier
unii: 37JNS02E7V
HUMCO 1 Percent IodineISOPROPYL ALCOHOLHumco Holding Group, Inc.139efeef-be20-4362-a5ba-158b8fa40e0d2025-09-22WarningsExact identifier
unii: ND2M416302
Xpect Isopropyl AlcoholISOPROPYL ALCOHOLCintas Corpb55fe473-45d2-48d3-b4d4-fc0993cb4dfe2025-09-22WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.00c486b0-bd7b-4898-834d-8c656e5e73cb2025-09-18Warnings, Adverse reactionsExact identifier
rxcui: 797544
8d50c0b0-e240-4527-bafe-0025a86c0c0219afe51a-3b2d-4286-ad32-992a34bba6482025-09-16Warnings, Adverse reactionsExact identifier
spl set id: 19afe51a-3b2d-4286-ad32-992a34bba648
RYONCILREMESTEMCEL-L-RKNDMesoblasta4e0918f-7444-4694-adeb-d38d983456592025-09-11Warnings, Adverse reactionsExact identifier
rxcui: 797544
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: 451W47IQ8X
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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