FDA.reportPublic FDA data

NDC 0781-5310-06 - 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
0781-5310
Requested NDC
0781-5310-06
Package NDCs from labels
0781-5310-06, 0781-5310-08
Manufacturer
Sandoz Inc
Effective date
2020-02-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Risperidone - Sandoz IncSandoz Inc2020-02-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5310-06EA - Each0781-5310ec1914e6-1ce9-4809-a4c1-e0272008315212016-12-07
0781-5310-08EA - Each0781-531097860a61-7a63-4ec7-bbee-75255656e30d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
ACESULFAMEINACTIVE INGREDIENTMA3UYZ6K1HRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ARISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TRISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8
SUCROSEINACTIVE INGREDIENTC151H8M554RISPERIDONE TABLET, ORALLY DISINTEGRATING [SANDOZ INC]8

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 2 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
RisperidoneRISPERIDONEREMEDYREPACK INC.c84807bd-35d7-4138-8989-42617d69293a2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONECoupler LLC52bb35ac-1f7d-bfbe-e063-6294a90aa2b92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERDALRISPERIDONEJanssen Pharmaceuticals, Inc.7e117c7e-02fc-4343-92a1-230061dfc5e02026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
RisperidoneRISPERIDONEREMEDYREPACK INC.8a4158fe-37d4-4c97-9c44-1c3489fe2a9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RisperidoneRISPERIDONEREMEDYREPACK INC.ab1cf6fd-9932-47fc-8736-476cc53a13fa2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
risperidoneRISPERIDONECardinal Health 107, LLC3ce21196-4aa0-469b-8f04-6650b2c48cb52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
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

Reported adverse events (FAERS/openFDA)#

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