FDA.reportPublic FDA data

NDC 70518-3741-1 - Risperidone

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
70518-3741
Requested NDC
70518-3741-1
Package NDCs from labels
70518-3741-1, 70518-3741-0
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SORBITOL SOLUTION - REMEDYREPACK INC.REMEDYREPACK INC.2026-04-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3741-0Risperidone10 in 1 BOXSOLUTION105
70518-3741-1Risperidone2 mL in 1 CUP, UNIT-DOSESOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3741RISPERIDONE SOLUTION [REMEDYREPACK INC.]3Current NDC, 2 package rows20240329_8a4158fe-37d4-4c97-9c44-1c3489fe2a9f.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 1 of 16 · 306 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEAPOZEAL PHARMACEUTICALS INC4ab6d256-6590-45be-a5df-f505987f96c32026-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199387
unii: L6UH7ZF8HC
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RisperidoneRISPERIDONEJanssen Pharmaceuticals, Inc.701e1cd8-2868-4d29-85a9-a2212c88165f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199387
unii: L6UH7ZF8HC
MENTOL CHINO FORTEMETHYL SALICYLATE, MENTHOL, CAMPHORLABORATORIOS H.G. C.A.12652c98-e2a8-21fc-e063-6394a90a94cb2026-08-17WarningsExact identifier
unii: 8SKN0B0MIM
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: 8SKN0B0MIM
RenapathBENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, DNA, EUPATORIUM PURPUREUM, GLANDULA SUPRARENALIS SUIS, HYDRANGEA ARBORESCENS, HYPOTHALAMUS, MERCURIUS CORROSIVUS, PANCREAS SUIS, PAREIRA BRAVA, PETROSELINUM SATIVUM, PITUITARUM POSTERIUM, RUBIA TINCTORUM, SARSAPARILLA, SOLIDAGO VIRGAUREA, THYROIDINUM (BOVINE), UVA-URSIEnergetix Corporation1a37b994-9470-4266-a4e1-008538ea0edf2026-08-11WarningsExact identifier
unii: 8SKN0B0MIM
RISPERIDONERISPERIDONEAmerisyn LLC58b7504f-c4a3-ef1b-e063-6394a90ac0f32026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Arnicare ArthritisARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAFLaboratoires Boironcb02378b-617d-4268-b565-4136e50009f42026-07-21Exact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RISPERIDONERISPERIDONECoupler LLC5643c32b-310e-4888-e063-6394a90ab62f2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEATLANTIC BIOLOGICALS CORP.dc8c6638-f487-49df-a265-78caa93e43d82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA079059
rxcui: 199387
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.ee495f20-c668-4d8f-9684-1029a4f232db2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONECoupler LLC55f3ebec-a742-48fc-e063-6394a90a14522026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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