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 9 of 153 · 3,052 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
unii: L7T10EIP3A
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
unii: L7T10EIP3A
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
unii: L7T10EIP3A
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
unii: L7T10EIP3A
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
unii: L7T10EIP3A
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
unii: L7T10EIP3A
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
unii: L7T10EIP3A
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
unii: L7T10EIP3A
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
unii: L7T10EIP3A
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
unii: L7T10EIP3A
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
unii: L7T10EIP3A
Lidocaine Pain Relief Gel-PatchLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.49bcdf68-d8f4-64d8-e063-6394a90a97172026-07-16WarningsExact identifier
unii: L7T10EIP3A
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
unii: L7T10EIP3A
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC56b8d0cc-2f35-7d38-e063-6294a90ad06d2026-07-16WarningsExact identifier
unii: L7T10EIP3A
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLOld East Main Co.7855033e-6a12-4cd8-b0a2-c5d69018d1172026-07-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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