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
Label	Manufacturer	Effective date	Type
Risperidone - Hikma Pharmaceutical \| Al Hikma Pharmaceuticals LLC	Hikma Pharmaceutical \| Al Hikma Pharmaceuticals LLC	2011-08-09	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RISPERIDONE 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 21 of 140 · 2,787 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	CALAMINE	AMERISOURCE BERGEN	90d9d908-57ea-4062-ade0-8a4888939c91	2026-01-29	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
SHISEIDO SPORTS BB DARK	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	f4fc4b6a-9507-496e-9ecb-8400055ecf2d	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Hampton Sun SPF 30 Mineral	ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	b8ee428e-07d3-4c6c-853c-cfbe3e4002d9	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	2776a647-678d-465c-9db3-4a9459ce779e	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO	LE COSMETICS INC	49643a56-3627-67f8-e063-6294a90a2d7b	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS	LE COSMETICS INC	49644002-153e-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee7d6779-7421-4761-99d2-ccbfde9385a8	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	101b2d4d-4740-4225-94bc-aecc05d82c6b	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
SURFERS BARRIER SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Avasol LLC	ec55eef0-17e6-416d-bd5e-548f2f323cea	2026-01-26	Warnings	Exact identifier unii: 15FIX9V2JP
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	65e70306-9e79-494d-9217-a43002f16307	2026-01-23	Warnings	Exact identifier unii: 15FIX9V2JP
O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum	TITANIUM DIOXIDE	LG Household and Healthcare, Inc.	c15ffd23-271d-458d-9048-9bc50331d5d7	2026-01-23	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	48f6361d-d738-62df-e063-6294a90aaac5	2026-01-22	Warnings	Exact identifier unii: 15FIX9V2JP
SOLBAR SUNSCREEN 40 SHIELD	SUNSCREEN	Person and Covey	48fcd463-8ce4-1e78-e063-6394a90a98e7	2026-01-22	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	be9f7608-cfaa-4b16-83dd-0580047af56c	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6b27df44-c441-4ae8-a1b0-a9cf2fff6f21	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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