FDA.reportPublic FDA data

NDC 71288-350 - 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
71288-350
Package NDCs from labels
71288-350-91
Manufacturer
Meitheal Pharmaceuticals Inc
Effective date
2026-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate - Meitheal Pharmaceuticals IncMeitheal Pharmaceuticals Inc2026-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-350-91Leuprolide Acetate0.5 mL in 1 PACKETSWAB14 mL0.35 mL in 0.5mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-350LEUPROLIDE ACETATE KIT [MEITHEAL PHARMACEUTICALS INC]1Unmatched20240515_d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584.zip

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 70 of 88 · 1,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOL SPRAYDynarex Corporation116e0c9c-cbe0-bf67-e063-6394a90ae5302024-02-15WarningsExact identifier
unii: ND2M416302
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Dysbio PlusACETICUM ACIDUM, ALOE, ARSENICUM ALBUM, BOTULINUM, BRUGIA MALAYI, CHININUM SULPHURICUM, CHOLERA NOSODE, CLOSTRIDIUM DIFFICILE, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, ECHINACEA (ANGUSTIFOLIA), HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, MERCURIUS CORROSIVUS, MORGAN GAERTNER, NUX VOMICA, PROTEUS (VULGARIS), SALMONELLA TYPHI NOSODEDeseret Biologicals, Inc.6864ab8e-3cf9-460e-b471-84ba3fb2efe02024-02-07WarningsExact identifier
unii: Q40Q9N063P
Dysbio PlusECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYIDeseret Biologicals, Inc.974f23e5-9062-42c1-9df3-12168edee1412024-02-07WarningsExact identifier
unii: Q40Q9N063P
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACIDCosette Pharmaceuticals, Inc.cef3713f-11f3-4723-9267-3d79855b49bf2024-02-02Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
unii: ND2M416302
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
unii: ND2M416302
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 451W47IQ8X
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 451W47IQ8X
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: 451W47IQ8X
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
unii: ND2M416302
American Safety First Aid AntispeticISOPROPYL ALCOHOLOrazen Incea302ba4-a63d-e713-e053-2995a90a3fc42024-01-15WarningsExact identifier
unii: ND2M416302
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
unii: 451W47IQ8X
Alcohol Prep PadALCOHOL PREP PADBioMed Resource Inc.03be8a96-c163-0e22-e054-00144ff8d46c2024-01-10WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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