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 8 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOCOR	SIMVASTATIN	Organon LLC	8f55d5de-5a4f-4a39-8c84-c53976dd6af9	2025-03-28	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Ezetimibe	EZETIMIBE	Aurobindo Pharma Limited	726b1e63-437a-4b3b-b773-3ac47a5c0f38	2025-03-13	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Ezetimibe	EZETIMIBE	NorthStar Rx LLC	5f5644a9-e019-4e5d-ab6f-3d30b1024c5a	2025-03-13	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
Alka-Seltzer Heartburn Relief Extra Strength	ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)	Bayer Healthcare LLC	dc1641f8-54c2-0d86-e053-2995a90a1dce	2025-03-11	Warnings	Exact identifier unii: 2968PHW8QP
Ezetimibe	EZETIMIBE	Proficient Rx LP	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	2025-03-01	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
YVTYVT MICRODERMABRASION FACIAL SCRUB	YVTYVT MICRODERMABRASION FACIAL SCRUB	Beijing JUNGE Technology Co., Ltd.	2f30fc45-42e2-c766-e063-6394a90a8d68	2025-02-28	Warnings	Exact identifier unii: OP1R32D61U
Simvastatin	SIMVASTATIN	A-S Medication Solutions	492f6b4e-ca25-4f59-9f9d-3f465061b7b1	2025-02-12	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf85b795-82fa-3389-e053-2995a90af2fd	2025-02-10	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	cf859977-2d84-0fcb-e053-2a95a90a6269	2025-02-10	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Ezetimibe	EZETIMIBE	Amneal Pharmaceuticals NY LLC	3fadf4e9-017d-4ccd-91dc-a89b981eb138	2025-02-10	Warnings, Adverse reactions	Exact identifier unii: EOR26LQQ24
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	06703194-b41a-2bbe-e063-6394a90ac41f	2025-02-04	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	0a1fe17b-75d4-d361-e063-6394a90ae188	2025-02-03	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	673dfc44-d407-f9ac-e053-2a91aa0a4702	2025-02-03	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Anticoagulant Citrate Dextrose A ACD-A	ANTICOAGULANT CITRATE DEXTROSE A ACD-A	Arteriocyte Medical Systems, Inc.	b850deac-161f-4bb0-ac7f-bceac2a230c0	2025-01-23		Exact identifier unii: 2968PHW8QP
Simvastatin	SIMVASTATIN	Direct_Rx	f42246de-62d2-212f-e053-2a95a90ac88a	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Direct_Rx	f5dd1835-6d40-40da-e053-2a95a90ad121	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Direct_Rx	f7aa095f-590c-98e3-e053-6394a90ad972	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
ACD A	DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE	Terumo BCT Ltd	570770de-9b48-4fc1-a1ee-06002ca9504f	2025-01-22		Exact identifier unii: 2968PHW8QP
Anticoagulant Citrate Dextrose (ACD-A)	DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATE	Terumo BCT, Ltd	0130d7c8-d067-4528-beb7-166559c33be9	2025-01-21	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
Soothe Chewable	CITRIC ACID	Carolina Cannabis Creations LLC	04a27a71-b7b2-12aa-e063-6294a90a312f	2025-01-15	Warnings	Exact identifier unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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