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 54 of 88 · 1,742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a678fac-289c-0f5c-e053-2995a90a0f432025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66da0b-ee7b-2b69-e053-2995a90ae9512025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a667d80-d05c-2d18-e053-2995a90a29182025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66e2a9-a661-e847-e053-2a95a90aa3042025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67a0bb-6943-2f5f-e053-2a95a90aac6e2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a6711a9-e0a4-9083-e053-2a95a90ad4a42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67bb27-cb44-4a1d-e053-2a95a90a0ee22025-01-09Exact identifier
unii: Q40Q9N063P
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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