FDA.reportPublic FDA data

NDC 71288-565 - 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
71288-565
Package NDCs from labels
71288-565-03
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
71288-565-03Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL2
71288-565-03Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-565LEUPROLIDE 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 25 of 91 · 1,818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoubleDex KitDEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINEAsclemed USA, Inc.b7d58d9b-e1fa-4a7f-afca-beb06d0280572026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 797544
Mardex 25 KitDEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.94472ddb-ae1d-4a11-a673-81254d562e6b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Marlido 25 KitLIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.1fe460e7-208d-410e-84c5-cd63005cff472026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.35ffe071-8bc1-4c88-8c85-645847acf1692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Marbeta L KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.9a6a3871-4e02-47f9-a20e-a256b3f3c4982026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAsclemed USA, Inc.e9f7f923-e7f9-4c52-b56d-914d800c1acf2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural L KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.4879f990-e879-47e1-99bc-b4bfcb32bcff2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 797544
Multi-Specialty KitDEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.5f2768d1-90c4-4d73-902d-fc7a947da7a52026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 797544
Ketorocaine L KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.ee0d396c-5caa-4a1a-9865-1a742d9d8d682026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural LM KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.cdd72141-10b6-48c6-85be-5b1294c8539c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.57ac1673-0652-433b-8b79-962d14e5b3172026-01-08WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHenry Schein Inc.eeaf255e-497b-4672-bebc-4d3fcba904c72026-01-08WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL7-Eleven, Inc.96d0488b-decd-4ffc-9179-29905a436bb12026-01-08WarningsExact identifier
unii: ND2M416302
Handy Solutions Rubbing AlcoholISOPROPYL ALCOHOLNavajo Manufacturing Company Inc.86268942-5526-47f6-b130-1b260d5a24032026-01-08WarningsExact identifier
unii: ND2M416302
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
AlcoholALCOHOLSion Biotext Medical Ltd7786a427-ac2b-46ed-b98e-3f2b22e15d2f2026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
alcoholALCOHOLSion Biotext Medical Ltd671e9fa9-a4b8-42a2-bd6f-490bc902a86e2026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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