FDA.reportPublic FDA data

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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5653-02019-09-24C16284748780-19350213a-485f-c013-e053-90daa90a1393Advicor ® (niacin extended-release/lovastatin tablets)
54868-5653-12019-09-24C16284748780-19350213a-485f-c013-e053-90daa90a1393Advicor ® (niacin extended-release/lovastatin tablets)

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