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 106 of 137 · 2,722 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	1acd3f09-87f2-75e4-e063-6394a90a0cd9	2024-06-13	Warnings	Exact identifier unii: 15FIX9V2JP
Cold Sore Rescue	BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA	Peaceful Mountain, Inc.	a7fe6ec7-a758-43cf-b46f-c327e0632fb8	2024-06-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	79648a52-1364-c25b-e053-2a91aa0a8ea4	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
SILICEA	SILICEA	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	1a361030-a925-0998-e063-6394a90a915d	2024-06-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Youth 3 Activating BB Cream SPF 30 Medium	ZINC OXIDE, TITANIUM DIOXIDE	Shaklee Corporation	ccc80ea4-f270-4fd4-970c-eaa63df936e4	2024-06-06	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
toty Solaria Body	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	CHIPICAN LLC	1a121b17-3621-6bc1-e063-6394a90ac9a1	2024-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	0b62062d-b77e-4e6c-b3ab-b35ab24db7cb	2024-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	19b19023-1340-6609-e063-6394a90a6eaf	2024-05-30	Warnings	Exact identifier unii: 15FIX9V2JP
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	420cfeef-0061-43b9-9491-dbd6ad866e55	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	aab773b2-a605-4cf8-a301-57e390fe67a6	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	2f83d3e9-04ab-4b24-ad1f-7ed2e784298a	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: L6UH7ZF8HC
COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee2842c3-65e0-3904-e053-2a95a90aabff	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Firecracker	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee026a1c-885b-256f-e053-2a95a90af564	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ec96dee8-85e8-3147-e053-2995a90aaf53	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess	TITANIUM DIOXIDE	COOLA, LLC	eeb406c6-a543-379a-e053-2995a90a4998	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose	TITANIUM DIOXIDE	COOLA, LLC	ee01642f-478e-b307-e053-2a95a90a7d81	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Untinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ecabcc89-fb09-41a9-e053-2995a90a8b31	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Tinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee018c21-dca7-28aa-e053-2a95a90a3bdb	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Golden Daze	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eeb70034-0f8d-a46d-e053-2a95a90a8130	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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