FDA.reportPublic FDA data

NDC 70518-3741-01 - 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
70518-3741-01
Package NDCs from labels
70518-3741-1, 70518-3741-0, 70518-3741-01
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 3 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 8SKN0B0MIM
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 8SKN0B0MIM
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
RisperidoneRISPERIDONEPD-Rx Pharmaceuticals, Inc.e72a2768-815f-47bf-b2f9-16a93dd106842026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONECoupler LLC50216d94-7667-bd6a-e063-6394a90a81552026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: W4888I119H
RisperidoneRISPERIDONEREMEDYREPACK INC.8a4158fe-37d4-4c97-9c44-1c3489fe2a9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA079059
ndc (package): 70518-3741-1
ndc (package): 70518-3741-0
ndc (product): 70518-3741
ndc11 (package): 70518374101
rxcui: 199387
spl id: 4f81da24-3508-7699-e063-6394a90a3c19
spl set id: 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEREMEDYREPACK INC.ab1cf6fd-9932-47fc-8736-476cc53a13fa2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 199387
unii: L6UH7ZF8HC
risperidoneRISPERIDONECardinal Health 107, LLC3ce21196-4aa0-469b-8f04-6650b2c48cb52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
RisperidoneRISPERIDONESolco Healthcare US, LLC43aa2a4f-1123-4f86-800b-9218882f7bcd2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEAmici Pharma, Inc.ca41c144-224a-4d57-88d7-8778e6c69ed22026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEPD-Rx Pharmaceuticals, Inc.bdb08381-dbfc-442e-8d3c-22d3a0f2f6c52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Advance PlusCARDUUS MARIANUS, CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA (ALBA), CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, URICUM ACIDUMVitaminMed, LLC97824fb3-e2b4-4807-943b-88e26b211bf12026-03-06WarningsExact identifier
unii: 8SKN0B0MIM
RisperidoneRISPERIDONETorrent Pharmaceuticals Limiteda6347895-5f16-43b4-92a0-b9904ac819372026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC

Reported adverse events (FAERS/openFDA)#

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