NDC 66582-313-01 - VYTORIN

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: 66582-313
Requested NDC: 66582-313-01
Package NDCs from labels: 66582-313-31, 66582-313-54, 66582-313-74, 66582-313-86, 66582-313-01, 66582-313-52, 66582-313-27
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Effective date: 2022-03-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
VYTORIN - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2022-03-07	HUMAN PRESCRIPTION DRUG LABEL
VYTORIN - Merck Sharp & Dohme Corp.	Merck Sharp & Dohme Corp.	2020-12-05	HUMAN PRESCRIPTION DRUG LABEL
VYTORIN - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-09-06	HUMAN PRESCRIPTION DRUG LABEL
VYTORIN - Rebel Distributors Corp	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66582-313-31	EA - Each	66582-313	f5a0c56b-9e41-4008-8210-4abe93a99f40	1	2012-07-24
66582-313-54	EA - Each	66582-313	bcb56bc9-5869-47b8-a039-c2bff32e53bb	1	2012-07-24
66582-313-74	EA - Each	66582-313	25f151d7-3f75-47ca-adfa-1fc83cd5a08f	1	2012-07-24
66582-313-86	EA - Each	66582-313	e5abeb51-591b-4538-88bd-7fef1d1e6b7c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
ezetimibe	ACTIVE MOIETY	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
simvastatin	ACTIVE MOIETY	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [MERCK SHARP & DOHME CORP.]	43
ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
ezetimibe	ACTIVE MOIETY	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
simvastatin	ACTIVE MOIETY	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.]	22
ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ezetimibe	ACTIVE MOIETY	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
simvastatin	ACTIVE MOIETY	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ezetimibe	ACTIVE INGREDIENT	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
simvastatin	ACTIVE INGREDIENT	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
ezetimibe	ACTIVE MOIETY	EOR26LQQ24	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
simvastatin	ACTIVE MOIETY	AGG2FN16EV	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]	1

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Soothe Chewable	CITRIC ACID	Carolina Cannabis Creations LLC	04a7720f-1e74-7578-e063-6394a90a5eae	2025-01-15	Warnings	Exact identifier unii: 2968PHW8QP
Soothe Chewable	CITRIC ACID	Carolina Cannabis Creations LLC	04a78060-7f0d-c4bd-e063-6294a90ae152	2025-01-15	Warnings	Exact identifier unii: 2968PHW8QP
Soothe Chewable	CITRIC ACID	Carolina Cannabis Creations LLC	04a78a5c-e3b5-f362-e063-6394a90a0807	2025-01-15	Warnings	Exact identifier unii: 2968PHW8QP
D-99	ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATE	DNA Labs, Inc.	dd9c0226-35ea-445a-a570-1ec35551f68d	2025-01-13	Warnings	Exact identifier unii: 2968PHW8QP
D-97	ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATE	DNA Labs, Inc.	b2079abb-786c-4f92-8d49-5606c77f7d72	2025-01-13	Warnings	Exact identifier unii: 2968PHW8QP
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	56456210-2db5-4f0d-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
ezetimibe	EZETIMIBE	Zydus Lifesciences Limited	de814dcd-4759-4e9c-a650-335fb885a79d	2024-11-28		Exact identifier unii: EOR26LQQ24
Potassium Citrate and Citric Acid	POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE	PAI Holdings, LLC dba PAI Pharma	ce42122f-8087-471f-b0a3-5524bdbd4526	2024-11-19	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
TRICITRATES	POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE	PAI Holdings, LLC dba PAI Pharma	2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad	2024-11-15	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Sal de Uvas Picot	CITRIC ACID MONOHYDRATE AND SODIUM BICARBONATE	RB Health Mexico, S.A. de C.V.	151b9bc9-1a6e-4401-ae58-4b4210ab4505	2024-11-15	Warnings	Exact identifier unii: 2968PHW8QP
Lungex II	GINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUS	Energique, Inc.	ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b	2024-10-28	Warnings	Exact identifier unii: 2968PHW8QP
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Aurobindo Pharma Limited	79dadfde-35c7-4937-9c82-1728fb6be2fb	2024-10-22	Warnings, Adverse reactions	Exact identifier rxcui: 476351 rxcui: 476345 rxcui: 476349 rxcui: 476350 unii: AGG2FN16EV unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	A-S Medication Solutions	5877150f-2807-435e-8e5b-a07dc7dbfd27	2024-10-21	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	A-S Medication Solutions	1afdb764-c5da-4982-beae-9be61bdcbcdc	2024-10-21	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	A-S Medication Solutions	63ecbbf1-a6de-493f-9710-812ff45cb4d3	2024-09-29	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier unii: 3NXW29V3WO
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	1ddc0230-24ab-4e69-9c6c-6776c354c82c	2024-09-13	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV

Reported adverse events (FAERS/openFDA)#

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