Advicor

Product NDC
54868-5653
11-digit product format
548685653
Labeler code
54868
Product ID
54868-5653_0b937ee5-f2c3-48a9-87d2-f0689ff39043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
niacin and lovastatin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Physicians Total Care, Inc.
Application
NDA021249
Marketing category
NDA
Marketing start
2006-08-08
Marketing end
0000-00-00
Substance
NIACIN; LOVASTATIN
Active strength
1000 mg/1; mg/1
Pharmacologic classes
Nicotinic Acid [EPC],Nicotinic Acids [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54868-5653IInactivated by FDA2026-10-05
excluded packagepackage54868-565354868-5653-0IInactivated by FDA2026-10-05
excluded packagepackage54868-565354868-5653-1IInactivated by FDA2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54868-5653-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54868-5653-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54868-5653-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54868-5653-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54868-5653-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54868-5653-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54868-5653-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54868-5653-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54868-5653-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54868-5653-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54868-5653-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54868-5653-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54868-5653-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54868-5653-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54868-5653-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54868-5653-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54868-5653-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54868-5653-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54868-5653-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54868-5653-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54868-5653-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54868-5653-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54868-5653-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54868-5653-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54868-5653-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54868-5653-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54868-5653-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54868-5653-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54868-5653-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54868-5653-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54868-5653-0fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54868-5653-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54868-5653-086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54868-5653-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54868-5653-0bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54868-5653-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54868-5653-08dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54868-5653-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54868-5653-0e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54868-5653-1e2bbac7714bc…27bdfed8d636…

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 conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5Product name120140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-5653-0Advicor30 in 1 BOTTLETABLET, EXTENDED RELEASE304
54868-5653-1Advicor90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5653-0EA - Each54868-5653c6aedfc0-0dbb-4632-a577-175af5cc354d12012-07-24
54868-5653-1EA - Each54868-5653c682b7a3-2761-4953-879f-11cdf87af62212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
NIACINACTIVE INGREDIENT2679MF687AADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
LOVASTATINACTIVE MOIETY9LHU78OQFDADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
NIACINACTIVE MOIETY2679MF687AADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5653ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4Legacy NDC, 2 package rows20121008_dbdee4c0-86fa-4857-b536-79bf9ebb911a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
791834Advicor 1000 MG / 20 MG 24HR Extended Release Oral TabletPSNdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791846Advicor 1000 MG / 40 MG 24HR Extended Release Oral TabletPSNdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791838Advicor 500 MG / 20 MG 24HR Extended Release Oral TabletPSNdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791842Advicor 750 MG / 20 MG 24HR Extended Release Oral TabletPSNdbdee4c0-86fa-4857-b536-79bf9ebb911a4
644112niacin 1000 MG / lovastatin 40 MG 24HR Extended Release Oral TabletPSNdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183424 HR lovastatin 20 MG / niacin 1000 MG Extended Release Oral Tablet [Advicor]SBDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183824 HR lovastatin 20 MG / niacin 500 MG Extended Release Oral Tablet [Advicor]SBDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184224 HR lovastatin 20 MG / niacin 750 MG Extended Release Oral Tablet [Advicor]SBDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184624 HR lovastatin 40 MG / niacin 1000 MG Extended Release Oral Tablet [Advicor]SBDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204124 HR lovastatin 20 MG / niacin 1000 MG Extended Release Oral TabletSCDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204224 HR lovastatin 20 MG / niacin 500 MG Extended Release Oral TabletSCDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204324 HR lovastatin 20 MG / niacin 750 MG Extended Release Oral TabletSCDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
64411224 HR lovastatin 40 MG / niacin 1000 MG Extended Release Oral TabletSCDdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204124 HR Lovastatin 20 MG / nicotinic acid 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183424 HR Lovastatin 20 MG / nicotinic acid 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204224 HR Lovastatin 20 MG / nicotinic acid 500 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183824 HR Lovastatin 20 MG / nicotinic acid 500 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204324 HR Lovastatin 20 MG / nicotinic acid 750 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184224 HR Lovastatin 20 MG / nicotinic acid 750 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204124 HR Lovastatin 20 MG / vit-B3 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183424 HR Lovastatin 20 MG / vit-B3 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204224 HR Lovastatin 20 MG / vit-B3 500 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183824 HR Lovastatin 20 MG / vit-B3 500 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204324 HR Lovastatin 20 MG / vit-B3 750 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184224 HR Lovastatin 20 MG / vit-B3 750 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204124 HR Lovastatin 20 MG / vitamin B3 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183424 HR Lovastatin 20 MG / vitamin B3 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204224 HR Lovastatin 20 MG / vitamin B3 500 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79183824 HR Lovastatin 20 MG / vitamin B3 500 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
58204324 HR Lovastatin 20 MG / vitamin B3 750 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184224 HR Lovastatin 20 MG / vitamin B3 750 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
64411224 HR Lovastatin 40 MG / nicotinic acid 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184624 HR Lovastatin 40 MG / nicotinic acid 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
64411224 HR Lovastatin 40 MG / vit-B3 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184624 HR Lovastatin 40 MG / vit-B3 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
64411224 HR Lovastatin 40 MG / vitamin B3 1000 MG Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
79184624 HR Lovastatin 40 MG / vitamin B3 1000 MG Extended Release Oral Tablet [Advicor]SYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791834Advicor 1000/20 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791846Advicor 1000/40 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791838Advicor 500/20 (niacin / lovastatin) 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791838Advicor 500/20 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
791842Advicor 750/20 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
582041lovastatin 20 MG / niacin 1000 MG 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
582042lovastatin 20 MG / niacin 500 MG 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
582043lovastatin 20 MG / niacin 750 MG 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
644112lovastatin 40 MG / niacin 1000 MG 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4
644112lovastatin 40 MG / vitamin B3 1000 MG 24 HR Extended Release Oral TabletSYdbdee4c0-86fa-4857-b536-79bf9ebb911a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54868-5653-05486856530030 in 1 BOTTLEHistorical
54868-5653-15486856530190 in 1 BOTTLEHistorical