FDA.reportPublic FDA data

NDC 59115-089-55 - 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
59115-089
Requested NDC
59115-089-55
Package NDCs from labels
59115-089-55, 59115-089-60
Manufacturer
Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC
Effective date
2011-08-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Risperidone - Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLCHikma Pharmaceutical | Al Hikma Pharmaceuticals LLC2011-08-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TRIACETININACTIVE INGREDIENTXHX3C3X673RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6

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 54 of 137 · 2,738 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST3728ec6a-7de5-bbc5-e063-6294a90a31b72025-12-11Exact identifier
unii: 15FIX9V2JP
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db5721-2b32-d4d8-e063-6294a90a47d72025-12-11Exact identifier
unii: 15FIX9V2JP
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db14e1-f995-b649-e063-6294a90afd692025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351d27e3-00d4-8d31-e063-6394a90aaf722025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351db99e-262f-b67e-e063-6394a90a34182025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDAISY'S SKIN TRANSFORMATION LLC37d9fbf5-d602-d3dc-e063-6394a90abe532025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
unii: 15FIX9V2JP
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
unii: 15FIX9V2JP
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
unii: 15FIX9V2JP
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
unii: 15FIX9V2JP
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
unii: 15FIX9V2JP
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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