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 4 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	25d9f841-31d8-4514-ac73-ffe138ff69c7	2026-02-26	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Tricitrates	TRICITRATES	Chartwell Governmental & Specialty RX, LLC.	c4ff0407-3930-4c48-afd4-d2cb3e1b18f4	2026-02-25	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Potassium Citrate and Citric Acid	POTASSIUM CITRATE AND CITRIC ACID	Chartwell Governmental & Specialty RX, LLC.	fd57a176-7faf-4053-b348-6ba5f192f05a	2026-02-25	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
EZETIMIBE	EZETIMIBE	Bryant Ranch Prepack	02b00cb2-7253-4fb4-a216-53691a929a28	2026-02-17	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	aaca7284-d2d8-42e3-b153-ddc3d2ce907c	2026-02-10	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	A-S Medication Solutions	2ce219a2-1eeb-4ece-bb87-3810e593ca51	2026-02-06	Warnings, Adverse reactions	Exact identifier rxcui: 476350 unii: AGG2FN16EV unii: EOR26LQQ24
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	76ea62f3-4efb-4649-829d-3f0c28d5dae7	2026-02-05	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	d099d003-4c7c-4e35-ad6e-94ddf20035b7	2026-02-03	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	3b0720d2-b240-48e4-af77-9ccda509fae7	2026-02-03	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Additive Formula 3	DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE	Terumo BCT, Ltd	9a5247a1-cc05-442d-b2d0-950f887f03c2	2026-01-30	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
SIMVASTATIN	SIMVASTATIN	REMEDYREPACK INC.	30fe2447-4dd3-43e6-bac5-0f754ab77c3a	2026-01-29	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
VYTORIN	EZETIMIBE AND SIMVASTATIN	Organon LLC	89b860d2-de83-468e-b7e8-76aeec2edca2	2026-01-21	Warnings, Adverse reactions	Exact identifier application number: NDA021687 rxcui: 476351 rxcui: 476345 rxcui: 476349 rxcui: 476350 rxcui: 1245441 rxcui: 1245449 rxcui: 1245420 rxcui: 1245430 unii: AGG2FN16EV unii: EOR26LQQ24
Simvastatin	SIMVASTATIN	XLCare Pharmaceuticals Inc.	433f8a86-5ad3-43db-8e62-c0812dd3d723	2026-01-19	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SWISS BLEU Relief-Calm Antimicrobial Skin Cream	LACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACID	Nanjing Hongruixing Biological Technology Co., Ltd	487d3c2c-ce28-f7a1-e063-6294a90a5ec6	2026-01-16	Warnings	Exact identifier unii: 2968PHW8QP
Ezetimibe	EZETIMIBE	AvPAK	6fcbfbd9-6e09-8224-e053-2a91aa0a8226	2026-01-13	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	3e48217f-8175-4e9b-9fd0-909be4bbba95	2026-01-13	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a	2026-01-01	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f32d512f-86fa-b70f-e053-2a95a90afd01	2026-01-01	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f7567996-4e81-7c12-e053-6394a90aa087	2026-01-01	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f835af8f-7d84-1978-e053-6294a90a22ae	2026-01-01	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV

Reported adverse events (FAERS/openFDA)#

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