FDA.reportPublic FDA data

Niaspan

Product NDC
21695-852
11-digit product format
216950852
Labeler code
21695
Product ID
21695-852_ccc64ee7-f581-493b-b8c2-6147a0db197e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020381
Marketing category
NDA
Marketing start
2010-03-10
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
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
21695-852-902019-09-24C16284748780-1934fe258-4b8d-48b1-e053-8cdaa90a720aThese 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
21695-852-90Niaspan90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-852-90EA - Each21695-8521d2abee4-6718-4d19-8306-90953a25df5112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIACINACTIVE INGREDIENT2679MF687ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
NIACINACTIVE MOIETY2679MF687ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-852NIASPAN (NIACIN) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_ccc64ee7-f581-493b-b8c2-6147a0db197e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSNccc64ee7-f581-493b-b8c2-6147a0db197e1
1098141niacin 500 MG 24HR Extended Release Oral TabletPSNccc64ee7-f581-493b-b8c2-6147a0db197e1
1098135Niaspan 1000 MG 24HR Extended Release Oral TabletPSNccc64ee7-f581-493b-b8c2-6147a0db197e1
1098142Niaspan 500 MG 24HR Extended Release Oral TabletPSNccc64ee7-f581-493b-b8c2-6147a0db197e1
109813524 HR niacin 1000 MG Extended Release Oral Tablet [Niaspan]SBDccc64ee7-f581-493b-b8c2-6147a0db197e1
109814224 HR niacin 500 MG Extended Release Oral Tablet [Niaspan]SBDccc64ee7-f581-493b-b8c2-6147a0db197e1
109813424 HR niacin 1000 MG Extended Release Oral TabletSCDccc64ee7-f581-493b-b8c2-6147a0db197e1
109814124 HR niacin 500 MG Extended Release Oral TabletSCDccc64ee7-f581-493b-b8c2-6147a0db197e1
109813524 HR Niaspan 1000 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814224 HR Niaspan 500 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813524 HR nicotinic acid 1000 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814224 HR nicotinic acid 500 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813524 HR vit-B3 1000 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814124 HR vit-B3 500 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814224 HR vit-B3 500 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109813524 HR vitamin B3 1000 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
109814224 HR vitamin B3 500 MG Extended Release Oral Tablet [Niaspan]SYccc64ee7-f581-493b-b8c2-6147a0db197e1
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
1098141niacin 500 MG 24 HR Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
1098135Niaspan 1000 MG 24 HR Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1
1098142Niaspan 500 MG 24 HR Extended Release Oral TabletSYccc64ee7-f581-493b-b8c2-6147a0db197e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-852-902169508529090 in 1 BOTTLEHistorical