FDA.reportPublic FDA data

NDC 0121-2105 - 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
0121-2105
Package NDCs from labels
0121-2105-01
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
leuprolide acetate - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2026-01-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-2105-01leuprolide acetate1 mL in 1 PACKETSWAB28 mL0.7 mL in 1mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-2105LEUPROLIDE ACETATE KIT [PAI HOLDINGS, LLC DBA PAI PHARMA]3Unmatched20250201_19be0b7f-e68a-4547-9e49-b51b12821907.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 33 of 88 · 1,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Leuprolide AcetateLEUPROLIDE ACETATEVGYAAN Pharmaceuticals LLCbec9077a-3f04-4887-856d-dde2de24584d2025-11-21Warnings, Adverse reactionsExact identifier
rxcui: 545835
rxcui: 797544
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Dukal Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC953b0dd6-a667-4146-815e-6845aba0309b2025-11-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Dukal Sterile Alcohol SwabstickISOPROPYL ALCOHOLDukal LLC8e47e9ad-cea4-76a4-e053-2a95a90ae7802025-11-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
AvonexINTERFERON BETA-1ABiogen Inc.d70a39cc-de15-4c12-a1ec-8063b69ea0e12025-11-19Warnings, Adverse reactionsExact identifier
rxcui: 797544
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
rxcui: 797544
unii: ND2M416302
BodyMed Alcohol Prep PadALCOHOL PREP PADBoxout, LLCd30dce9c-8d12-4c71-e053-2995a90a12052025-11-14WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Swimmers EarCLEARCANALNeilmed Pharmaceuticals Inc.43778b02-e90b-36b7-e063-6394a90ab62b2025-11-13WarningsExact identifier
unii: ND2M416302
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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