FDA.reportPublic FDA data

NIACIN

Product NDC
47335-539
11-digit product format
473350539
Labeler code
47335
Product ID
47335-539_bc18daa3-5321-43bd-9d00-dabd9adac571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIACIN
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200484
Marketing category
ANDA
Marketing start
2014-06-27
Substance
NIACIN
Active strength
500 mg/1
Pharmacologic classes
Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NIACIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2679MF687A
Rxcui1098134, 1098141, 1098143

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-539-08NIACIN100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10022
47335-539-18NIACIN1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100022
47335-539-81NIACIN90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9022
47335-539-83NIACIN30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3022
47335-539-88NIACIN100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-539-81EA - Each47335-539edda52e8-3322-4a92-83db-f9469c66b5c612014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIACINACTIVE INGREDIENT2679MF687ANIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
NIACINACTIVE MOIETY2679MF687ANIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
TALCINACTIVE INGREDIENT7SEV7J4R1UNIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-539NIACIN TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]22Current NDC, Legacy NDC, 5 package rows20231125_8e290f96-e8c6-47fd-863f-1c9480f28d9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR niacin 500 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR niacin 750 MG Extended Release Oral TabletSCD8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY8e290f96-e8c6-47fd-863f-1c9480f28d9b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-539-0847335053908100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08) 2014-06-270000-00-00NoNoCurrent
47335-539-18473350539181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18) 2014-06-270000-00-00NoNoCurrent
47335-539-814733505398190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81) 2014-06-270000-00-00NoNoCurrent
47335-539-834733505398330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-83) 2014-06-270000-00-00NoNoCurrent
47335-539-8847335053988100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88) 2014-06-270000-00-00NoNoCurrent