FDA.reportPublic FDA data

NDC 83634-453 - 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
83634-453
Package NDCs from labels
83634-453-01
Manufacturer
Avenacy, LLC
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate - Avenacy, LLCAvenacy, LLC2026-04-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-453-01Leuprolide Acetate1 mL in 1 PACKETSWAB28 mL0.7 mL in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-453LEUPROLIDE ACETATE KIT [AVENACY INC.]1Unmatched20250316_15003c37-6e91-4c79-a85c-3d03343b53f9.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 59 of 91 · 1,819 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Headache EaseAUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIASilver Star Brandsc689fb16-6200-ac94-e053-2995a90a703d2025-01-01WarningsExact identifier
unii: 451W47IQ8X
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: 451W47IQ8X
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD303097a0-8eb0-3e1c-e063-6394a90afab32025-01-01WarningsExact identifier
rxcui: 797544
unii: ND2M416302
BL-C KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINEAsclemed USA, Inc.798f3bc6-d976-49a6-87a2-fd30c784fc502024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
DG Health Sterile Saline MistSODIUM CHLORIDEDG Healthf2e44ab4-ae0f-c87b-e053-2a95a90acd042024-12-31WarningsExact identifier
unii: 451W47IQ8X
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAdvanced Rx Pharmacy of Tennessee, LLCfb81d452-30e0-f019-e053-6394a90a76342024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Multi-Specialty KitDEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLCfb85b480-d0cd-2539-e053-6294a90a50832024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 797544
DoubleDex KitDEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINEAdvanced Rx Pharmacy of Tennessee, LLCfb85dd2c-6c90-6249-e053-6294a90a09fa2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 797544
Betalido KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, POVIDINE IODINEAdvanced Rx Pharmacy of Tennessee, LLCfb5d3ec8-8866-881d-e053-6294a90a1cc52024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural 80-LMMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLC01ca7a2d-e8cb-c063-e063-6294a90ae7f92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLC01ca2f07-9c84-e418-e063-6294a90ac7602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Dyural 40 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAdvanced Rx Pharmacy of Tennessee, LLC01ca16de-ab2e-4e19-e063-6394a90a05102024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Acetic AcidACETIC ACIDTruPharma, LLC0c5ebd59-0e98-4ea1-b279-9202a19f6dbf2024-12-27Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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