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 2 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
RisperidoneRISPERIDONEAPOZEAL PHARMACEUTICALS INC4ab6d256-6590-45be-a5df-f505987f96c32026-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: L6UH7ZF8HC
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
unii: L7T10EIP3A
SYLVIRENE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a4fd689-2113-f15a-e063-6394a90a45ad2026-08-30WarningsExact identifier
unii: L7T10EIP3A
Rhinoost SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a296baa-c101-3192-e063-6394a90aa2b02026-08-29WarningsExact identifier
unii: L7T10EIP3A
LUCKSKY SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a29ee19-8b6d-b4fa-e063-6394a90ad81d2026-08-29WarningsExact identifier
unii: L7T10EIP3A
Flobow SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a2aa169-90b5-417f-e063-6394a90aa2782026-08-29WarningsExact identifier
unii: L7T10EIP3A
Hoxlbin SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a17b116-d573-1c4a-e063-6394a90a499b2026-08-28WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Unikinesys SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a275076-b75a-7d2c-e063-6294a90ad2222026-08-28WarningsExact identifier
unii: L7T10EIP3A
TideFresh SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a27a35c-8c6b-d298-e063-6294a90a13892026-08-28WarningsExact identifier
unii: L7T10EIP3A
Nrmrqz SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a27f471-e54e-cbbf-e063-6394a90aa8042026-08-28WarningsExact identifier
unii: L7T10EIP3A
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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