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 7 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EZETIMIBE	EZETIMIBE	Accord Healthcare Inc.	ceecdbe9-5404-4a93-a488-9211cd103058	2025-10-14	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	American Health Packaging	0e9a9eda-1b2a-4475-8483-0f410a17c524	2025-10-14	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4cfda5aa-e21a-47b2-b296-88d8336298ef	2025-10-14	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4158aa71-3540-4912-b909-7491e5a1429c	2025-10-14	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	A-S Medication Solutions	dd8a09cb-f014-4650-9da2-4ad1581c9741	2025-10-10	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Simvastatin	SIMVASTATIN	American Health Packaging	4bec3923-6221-4b8b-9a72-872a63680de1	2025-08-25	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Medique Medi Seltzer	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Unifirst First Aid Corporation	528da9d9-2a52-4c16-b7b2-61b3eee1abea	2025-08-19	Warnings	Exact identifier unii: 2968PHW8QP
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Dr.Reddys Laboratories Inc	023ca87a-1b04-8c17-dc4f-e2758b0771e2	2025-07-18	Warnings, Adverse reactions	Exact identifier rxcui: 476351 rxcui: 476345 rxcui: 476349 rxcui: 476350 unii: AGG2FN16EV unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	c92292f5-5444-4247-927e-db7bf6816109	2025-07-17	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	Ascend Laboratories, LLC	206d702c-b09a-4555-972b-6555d6d6d6e6	2025-06-13	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Simvastatin	SIMVASTATIN	American Health Packaging	51dd8d34-e660-49dc-a86e-07d031a18465	2025-05-20	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	3a80b668-51cd-42be-8497-8712b0508422	2025-05-12	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Phexx	LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE	Evofem, Inc.	14b01a15-9b47-4be3-bb2e-a2010eab429e	2025-05-02	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Ascend Laboratories, LLC	c90e8c96-e130-42d7-bf0d-5833652e40d5	2025-05-02	Warnings, Adverse reactions	Exact identifier rxcui: 476351 rxcui: 476345 rxcui: 476349 rxcui: 476350 unii: AGG2FN16EV unii: EOR26LQQ24
Tricitrates	TRICITRATES	Chartwell RX, LLC	2a80ea6b-6334-4c33-a35e-a5cb2939fbcb	2025-04-28	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Simvastatin	SIMVASTATIN	A-S Medication Solutions	6de29f85-92e9-4a28-9bcc-6789f2f698de	2025-04-25	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	A-S Medication Solutions	9133520e-1ffd-4ef1-bced-6b0c9a579f39	2025-04-24	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Westminster Pharmaceuticals, LLC	acaaab63-c9ff-44c9-8fde-9a4ea6454dd7	2025-04-21	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Potassium Citrate and Citric Acid	POTASSIUM CITRATE AND CITRIC ACID	Chartwell RX, LLC	978a5a9d-f0ca-4308-a84b-3b132263bbb8	2025-04-09	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Lemon Lime	ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)	Bayer Healthcare LLC	cc21af24-9a5b-6831-e053-2a95a90a0af4	2025-04-01	Warnings	Exact identifier unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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