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 3 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.	c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36	2026-05-12	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	QPharma, Inc	f71fc0ac-223e-18c1-e053-6394a90a45ca	2026-05-11	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Aurobindo Pharma Limited	4724dbb4-3613-4e6a-948f-a43d34f97f06	2026-05-11	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Coupler LLC	50733b85-067d-99c3-e063-6394a90a4244	2026-04-27	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	5c760852-800b-463e-8059-06a9a82c2225	2026-04-15	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	7abc03f8-9d5f-4f7d-9e32-fc463ec0597c	2026-04-15	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	807e5be4-6f87-48b4-8a3b-e4ad1061e706	2026-04-14	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4f20191a-9124-2525-e063-6294a90a8428	2026-04-10	Warnings	Exact identifier unii: 3NXW29V3WO
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID	Chartwell Governmental & Specialty RX, LLC	58c24504-47de-487a-ab8d-18add155ea95	2026-04-07	Adverse reactions	Exact identifier unii: 2968PHW8QP
LensMate Preservative-Free Artificial Tears	LUBRICANT EYE DROPS	YD BIO USA, INC.	4ebacb2b-9b2d-6bc1-e063-6294a90a3426	2026-04-05	Warnings	Exact identifier unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4ebc154b-128b-9dde-e063-6294a90ae00e	2026-04-05	Warnings	Exact identifier unii: 3NXW29V3WO
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	c03ab80c-a3ae-4634-a76b-f53740db76f5	2026-04-03	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Crocodile Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Crocodile Tears LLC	4df29336-ea0c-0484-e063-6294a90a685a	2026-03-26	Warnings	Exact identifier unii: 3NXW29V3WO
Simvastatin	SIMVASTATIN	Golden State Medical Supply, Inc.	4cc35f5f-2d3e-dedd-e063-6294a90a5cbe	2026-03-26	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	KC Pharmaceuticals, Inc	4de5c844-85ca-ff9f-e063-6394a90ac12c	2026-03-25	Warnings	Exact identifier unii: 3NXW29V3WO
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e4d8ebf3-7f9f-4725-a104-1d1bf6e6f768	2026-03-23	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	0ccb324f-877d-4f32-a769-7cd1637b7fad	2026-03-23	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
Artificial Tears	GLYCERIN	Preferred Pharmaceuticals Inc.	dd646c72-8f47-43c6-a734-db0dcc8cd4d1	2026-03-06	Warnings	Exact identifier unii: 3NXW29V3WO
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	00896fff-081d-4553-be8c-1999a8a73dda	2026-02-26	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	PD-Rx Pharmaceuticals, Inc.	143bf1d6-11c5-4a1f-b106-844e0435ee13	2026-02-26	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV

Reported adverse events (FAERS/openFDA)#

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