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 87 of 87 · 1,729 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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