FDA.reportPublic FDA data

Niaspan

Product NDC
68151-4068
11-digit product format
681514068
Labeler code
68151
Product ID
68151-4068_97bea64c-c8e2-4c8c-9586-430b7b19015a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020381
Marketing category
NDA
Marketing start
2010-06-29
Marketing end
0000-00-00
Substance
NIACIN
Active strength
500 mg/1
Pharmacologic classes
Nicotinic Acid [EPC],Nicotinic Acids [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4068-92020-01-31C16284748780-19d75b9d0-475f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4068-9Niaspan1 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIACINACTIVE INGREDIENT2679MF687ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
NIACINACTIVE MOIETY2679MF687ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4068NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140815_0dd18020-c211-423d-b3d8-a926ae626e14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN0dd18020-c211-423d-b3d8-a926ae626e142
1098142Niaspan 500 MG 24HR Extended Release Oral TabletPSN0dd18020-c211-423d-b3d8-a926ae626e142
109814224 HR niacin 500 MG Extended Release Oral Tablet [Niaspan]SBD0dd18020-c211-423d-b3d8-a926ae626e142
109814124 HR niacin 500 MG Extended Release Oral TabletSCD0dd18020-c211-423d-b3d8-a926ae626e142
109814224 HR Niaspan 500 MG Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142
109814224 HR nicotinic acid 500 MG Extended Release Oral Tablet [Niaspan]SY0dd18020-c211-423d-b3d8-a926ae626e142
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142
109814224 HR vit-B3 500 MG Extended Release Oral Tablet [Niaspan]SY0dd18020-c211-423d-b3d8-a926ae626e142
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142
109814224 HR vitamin B3 500 MG Extended Release Oral Tablet [Niaspan]SY0dd18020-c211-423d-b3d8-a926ae626e142
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142
1098142Niaspan 500 MG 24 HR Extended Release Oral TabletSY0dd18020-c211-423d-b3d8-a926ae626e142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4068-9681514068091 in 1 PACKAGEHistorical