FDA.reportPublic FDA data

Niacin

Product NDC
59651-019
11-digit product format
596510019
Labeler code
59651
Product ID
59651-019_8539231f-47da-402e-b05d-16c45cc3670c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209236
Marketing category
ANDA
Marketing start
2018-02-01
Substance
NIACIN
Active strength
750 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
NIACIN750 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
59651-019-05Niacin500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
59651-019-18Niacin180 in 1 BOTTLETABLET, EXTENDED RELEASE1807
59651-019-90Niacin90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-019-18EA - Each59651-01955afebb5-b69c-4325-a243-eff223b29a7f12018-04-19
59651-019-90EA - Each59651-0191cfa875e-a77a-4495-8b5f-c7fa91f5a3ac12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-019NIACIN TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 3 package rows20230219_43233a21-3f90-4c69-bbeb-f50d5f2d35ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814124 HR niacin 500 MG Extended Release Oral TabletSCD43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814324 HR niacin 750 MG Extended Release Oral TabletSCD43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY43233a21-3f90-4c69-bbeb-f50d5f2d35ae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-019-0559651001905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-05) 2018-02-010000-00-00NoNoCurrent
59651-019-1859651001918180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-18) 2018-02-010000-00-00NoNoCurrent
59651-019-905965100199090 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-019-90) 2018-02-010000-00-00NoNoCurrent