FDA.reportPublic FDA data

NDC 63304-643-11 - 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
63304-643
Requested NDC
63304-643-11
Package NDCs from labels
63304-643-30, 63304-643-05, 63304-643-11, 63304-643-17, 63304-643-69
Manufacturer
Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.
Effective date
2022-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Risperidone - Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2022-07-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-643-05Risperidone500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50011
63304-643-11Risperidone1 in 1 POUCHTABLET, ORALLY DISINTEGRATING111
63304-643-17Risperidone10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1011
63304-643-30Risperidone30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3011
63304-643-69Risperidone1 in 1 CARTONTABLET, ORALLY DISINTEGRATING111
63304-643-69Risperidone10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-643RISPERIDONE TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 6 package rows20220716_f91f551e-926f-440d-83d2-357e9d7484fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5

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 7 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
unii: L7T10EIP3A
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Non-proprietary nameHEADACHE PATCHNanjing 3H Medical Products Co.,Ltd.586d73f1-0b0b-f596-e063-6394a90a4d572026-08-06WarningsExact identifier
unii: L7T10EIP3A
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLLidl US, LLCaf0bda7c-591f-4451-bb47-b83c2b4193722026-08-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLLidl US, LLC832f976b-b2be-4e25-9712-796093cbf6842026-08-05Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Hempe HOT Muscle and Joint GelHEMPEHealthcare International Research Limited5854a80e-c92b-3ff5-e063-6294a90a2d052026-08-05WarningsExact identifier
unii: L7T10EIP3A
Green MARVEL PAIN RELIEFMENTHOL, CAMPHOR, METHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Lab9ff6e477-ef79-4a0c-9e21-8cae0e5d88102026-08-05WarningsExact identifier
unii: L7T10EIP3A
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsExact identifier
unii: L7T10EIP3A
Pain Relief Knee Gel-PatchLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.581eb783-92d3-07b1-e063-6394a90acc632026-08-03WarningsExact identifier
unii: L7T10EIP3A
Wini By Locsanity Advanced Formula Muscle Joint Relief BalmMETHYL SALICYLATE,CAMPHOR,MENTHOLLocsanity LLC5829b5d7-78d4-78a2-e063-6394a90a3dfc2026-08-03WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
unii: L7T10EIP3A
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 0E53J927NA
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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