FDA.reportPublic FDA data

Niacin

Product NDC
10135-614
11-digit product format
101350614
Labeler code
10135
Product ID
10135-614_33e9a963-426b-48fe-ac2a-34ec6e2151bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA203578
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
NIACIN
Active strength
1000 mg/1
Pharmacologic classes
Nicotinic Acid [EPC],Nicotinic Acids [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
10135-614-052020-01-31C16284748780-19d75b9cf-f3aa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use niacin extended-release tablets safely and effectively. See full prescribing information for niacin extended-release tablets. NIACIN extended-release tablets, film-coated, for oral use. Initial U.S. Approval: 1997
10135-614-302020-01-31C16284748780-19d75b9cf-f3aa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use niacin extended-release tablets safely and effectively. See full prescribing information for niacin extended-release tablets. NIACIN extended-release tablets, film-coated, for oral use. Initial U.S. Approval: 1997
10135-614-902020-01-31C16284748780-19d75b9cf-f3aa-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use niacin extended-release tablets safely and effectively. See full prescribing information for niacin extended-release tablets. NIACIN extended-release tablets, film-coated, for oral use. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-614-05Niacin500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE5001
10135-614-30Niacin30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301
10135-614-90Niacin90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-614-90EA - Each10135-614c742dac5-0334-4b8f-bc05-1276e87f188a12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-614NIACIN TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 3 package rows20160406_e80aadb4-0533-4887-8dbb-a75f0c739942.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSNe80aadb4-0533-4887-8dbb-a75f0c7399421
1098141niacin 500 MG 24HR Extended Release Oral TabletPSNe80aadb4-0533-4887-8dbb-a75f0c7399421
1098143niacin 750 MG 24HR Extended Release Oral TabletPSNe80aadb4-0533-4887-8dbb-a75f0c7399421
109813424 HR niacin 1000 MG Extended Release Oral TabletSCDe80aadb4-0533-4887-8dbb-a75f0c7399421
109814124 HR niacin 500 MG Extended Release Oral TabletSCDe80aadb4-0533-4887-8dbb-a75f0c7399421
109814324 HR niacin 750 MG Extended Release Oral TabletSCDe80aadb4-0533-4887-8dbb-a75f0c7399421
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814124 HR vit-B3 500 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814324 HR vit-B3 750 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
1098141niacin 500 MG 24 HR Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421
1098143niacin 750 MG 24 HR Extended Release Oral TabletSYe80aadb4-0533-4887-8dbb-a75f0c7399421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-614-0510135061405500 in 1 BOTTLE, PLASTICHistorical
10135-614-301013506143030 in 1 BOTTLE, PLASTICHistorical
10135-614-901013506149090 in 1 BOTTLE, PLASTICHistorical