FDA.reportPublic FDA data

Niaspan

Product NDC
68258-6037
11-digit product format
682586037
Labeler code
68258
Product ID
68258-6037_569ac5fc-e35b-4e0e-97d1-9327a1c1b511
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA020381
Marketing category
NDA
Marketing start
1997-07-28
Marketing end
0000-00-00
Substance
NIACIN
Active strength
1000 mg/1
Pharmacologic classes
Nicotinic Acid [EPC],Nicotinic Acids [CS]
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-6037-32019-11-27C16284748780-19855d018-d949-cd31-e053-dbdaa90ab51aThese 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
68258-6037-62019-11-27C16284748780-19855d018-d949-cd31-e053-dbdaa90ab51aThese 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
68258-6037-3Niaspan30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
68258-6037-6Niaspan60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6037NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 2 package rows20121011_414b3d30-cc7f-4f91-b21e-5090b7f5b529.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN414b3d30-cc7f-4f91-b21e-5090b7f5b5292
1098135Niaspan 1000 MG 24HR Extended Release Oral TabletPSN414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813524 HR niacin 1000 MG Extended Release Oral Tablet [Niaspan]SBD414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813524 HR Niaspan 1000 MG Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813524 HR nicotinic acid 1000 MG Extended Release Oral Tablet [Niaspan]SY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813524 HR vit-B3 1000 MG Extended Release Oral Tablet [Niaspan]SY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
109813524 HR vitamin B3 1000 MG Extended Release Oral Tablet [Niaspan]SY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292
1098135Niaspan 1000 MG 24 HR Extended Release Oral TabletSY414b3d30-cc7f-4f91-b21e-5090b7f5b5292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6037-36825860370330 in 1 BOTTLEHistorical
68258-6037-66825860370660 in 1 BOTTLEHistorical