Simcor

Product NDC: 54868-6169
11-digit product format: 548686169
Labeler code: 54868
Product ID: 54868-6169_85d265f2-9b74-42d3-9b33-c34573be8c1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: simvastatin and niacin
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Physicians Total Care, Inc.
Application: NDA022078
Marketing category: NDA
Marketing start: 2010-09-14
Marketing end: 0000-00-00
Substance: SIMVASTATIN; NIACIN
Active strength: 40 mg/1; mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54868-6169		I	Inactivated by FDA		2026-10-12
excluded package	package	54868-6169	54868-6169-0	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54868-6169-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54868-6169-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54868-6169-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54868-6169-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54868-6169-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54868-6169-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54868-6169-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54868-6169-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54868-6169-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54868-6169-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54868-6169-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54868-6169-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54868-6169-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54868-6169-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54868-6169-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54868-6169-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54868-6169-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54868-6169-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54868-6169-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54868-6169-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54868-6169-0	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54868-6169-0	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-6169-0	2019-09-24	C162847	48780-1	9350213a-46d3-c013-e053-90daa90a1393	These highlights do not include all the information needed to use SIMCOR ® safely and effectively. See full prescribing information for SIMCOR. SIMCOR (simvastatin/niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-6169-0	Simcor	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-6169-0	EA - Each	54868-6169	816a215c-7aec-4f09-b6ef-6fa9cdfe3506	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIACIN	ACTIVE INGREDIENT	2679MF687A	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
NIACIN	ACTIVE MOIETY	2679MF687A	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-6169	SIMCOR (SIMVASTATIN AND NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2	Legacy NDC, 1 package rows	20101004_dd749fb9-e279-4958-9534-ad75a5b6754b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN
2679MF687A	NIACIN	59-67-6	NIACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
761907	niacin 1000 MG / simvastatin 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	niacin 1000 MG / simvastatin 40 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	niacin 500 MG / simvastatin 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	niacin 750 MG / simvastatin 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	Simcor 1000 MG / 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	Simcor 1000 MG / 40 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	Simcor 500 MG / 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	Simcor 750 MG / 20 MG 24HR Extended Release Oral Tablet	PSN	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	24 HR niacin 1000 MG / simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SBD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	24 HR niacin 1000 MG / simvastatin 40 MG Extended Release Oral Tablet [Simcor]	SBD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	24 HR niacin 500 MG / simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SBD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	24 HR niacin 750 MG / simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SBD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761907	24 HR niacin 1000 MG / simvastatin 20 MG Extended Release Oral Tablet	SCD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	24 HR niacin 1000 MG / simvastatin 40 MG Extended Release Oral Tablet	SCD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	24 HR niacin 500 MG / simvastatin 20 MG Extended Release Oral Tablet	SCD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	24 HR niacin 750 MG / simvastatin 20 MG Extended Release Oral Tablet	SCD	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761907	24 HR nicotinic acid 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	24 HR nicotinic acid 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	24 HR nicotinic acid 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	24 HR nicotinic acid 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	24 HR nicotinic acid 500 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	24 HR nicotinic acid 500 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	24 HR nicotinic acid 750 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	24 HR nicotinic acid 750 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761907	24 HR vit-B3 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	24 HR vit-B3 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	24 HR vit-B3 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	24 HR vit-B3 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	24 HR vit-B3 500 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	24 HR vit-B3 500 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	24 HR vit-B3 750 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	24 HR vit-B3 750 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761907	24 HR vitamin B3 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	24 HR vitamin B3 1000 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	24 HR vitamin B3 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	24 HR vitamin B3 1000 MG / Simvastatin 40 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	24 HR vitamin B3 500 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	24 HR vitamin B3 500 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	24 HR vitamin B3 750 MG / Simvastatin 20 MG Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	24 HR vitamin B3 750 MG / Simvastatin 20 MG Extended Release Oral Tablet [Simcor]	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761907	niacin 1000 MG / simvastatin 20 MG 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999935	niacin 1000 MG / simvastatin 40 MG 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
761909	niacin 500 MG / simvastatin 20 MG 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
762970	niacin 750 MG / simvastatin 20 MG 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763228	Simcor 1000/20 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
999939	Simcor 1000/40 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763232	Simcor 500/20 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2
763236	Simcor 750/20 24 HR Extended Release Oral Tablet	SY	dd749fb9-e279-4958-9534-ad75a5b6754b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54868-6169-0	54868616900	30 in 1 BOTTLE, PLASTIC	Historical