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 25 of 88 · 1,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
alcoholALCOHOLSion Biotext Medical Ltd03d6c745-6ee3-4011-9d5d-c8a4f078eced2026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTDfafd197e-d036-5ce5-e053-6294a90a6da92026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD29269551-5610-2c5c-e063-6294a90a8a7e2026-01-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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