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 1 of 11 · 202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
RisperidoneRISPERIDONEAPOZEAL PHARMACEUTICALS INC4ab6d256-6590-45be-a5df-f505987f96c32026-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
RisperidoneRISPERIDONEJanssen Pharmaceuticals, Inc.701e1cd8-2868-4d29-85a9-a2212c88165f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
RISPERIDONERISPERIDONEAmerisyn LLC58b7504f-c4a3-ef1b-e063-6394a90ac0f32026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
RisperidoneRISPERIDONEANI Pharmaceuticals, Inc.1f47ec91-602f-4fba-8f7e-a5698760b6552026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
RISPERIDONERISPERIDONEREMEDYREPACK INC.03d3b52d-3a7d-4595-84c9-332da6ca91712026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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