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 20 of 91 · 1,819 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE PRODUCTS PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.77a60360-8bb5-43e9-b7e4-f71d2d488c442026-02-09WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Lifesciences Limited4bae0e2a-dd36-4987-85ee-36a52e642ec72026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 545835
rxcui: 797544
AlcoholISOPROPYL ALCOHOLA-S Medication Solutions6b8834be-0235-4f7c-8d52-c2f6aa2d30492026-02-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70% RubbingISOPROPYL ALCOHOLWalgreens Co.6ad37d18-5c19-4b5f-8313-edd430f84fb02026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.1473e6e4-dc5f-43d9-a249-111a181e3f762026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
ForPro Premium Sterile Antiseptic Isopropyl Alcohol PadsISOPROPYL ALCOHOLTng workdwide6cc2ccae-b288-473e-a736-0974c96dbb892026-02-05WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPharmacy Value Alliance, LLC528011d7-8c6d-4940-bee1-52b39acef40d2026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.14aecc7b-c68a-4cb9-863f-475e204f66a52026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee2026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b1b52183-3296-48b2-b3d3-821c141b0bea2026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ee67fb96-fa2c-4542-8fdb-f2ccd885ee532026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLDyad Medical Sourcing, LLCb5c9e222-10eb-4cea-af70-213a77fcc8652026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGoBrands, Inc.0fb3db50-4132-07dc-e063-6294a90a81682026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dff8c83-7c33-7bca-e063-6394a90a675f2026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dffba95-71c4-a2b0-e063-6394a90aaeb32026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
91% ISOPROPYL ALCOHOL91% ISOPROPYL ALCOHOLHy-Vee, Inc.497471bb-541c-f945-e063-6294a90adbb22026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLHy-Vee, Inc.4831eecf-d111-6f17-e063-6394a90a4ab92026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
0.9 percentsalineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd487cb4fc-2e0b-020f-e063-6294a90a45262026-02-03WarningsExact identifier
unii: 451W47IQ8X
0.9salineSODIUM CHLORIDEHuizhou Jinsheng Medical Technology Co., Ltd49e76aca-ca2b-3b95-e063-6394a90a875e2026-02-03WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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