FDA.reportPublic FDA data

Niacin

Product NDC
71741-020
11-digit product format
717410020
Labeler code
71741
Product ID
71741-020_984e26b5-be06-4b88-b13b-7488fcb46516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET
Route
ORAL
Labeler
Redmont Pharmaceuticals, LLC
Application
ANDA040378
Marketing category
ANDA
Marketing start
2000-05-03
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
Rxcui198024

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
71741-020-30Niacin30 in 1 BOTTLETABLET302
71741-020-60Niacin60 in 1 BOTTLETABLET602
71741-020-90Niacin90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71741-020-30EA - Each71741-02037f1211e-9022-4166-a5cd-41978dfc1bc312026-01-08
71741-020-60EA - Each71741-02001b487df-9154-4925-bece-bba6daf601d112026-01-08
71741-020-90EA - Each71741-0209f115663-8fe6-4c45-9d05-e10e5f4b43d012022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71741-020NIACIN TABLET [REDMONT PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 3 package rows20211224_f51f7e6d-b132-48d8-8bb1-54203472f0d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198024niacin 500 MG Oral TabletPSNf51f7e6d-b132-48d8-8bb1-54203472f0d82
198024niacin 500 MG Oral TabletSCDf51f7e6d-b132-48d8-8bb1-54203472f0d82
198024nicotinic acid 500 MG Oral TabletSYf51f7e6d-b132-48d8-8bb1-54203472f0d82
198024vit-B3 500 MG Oral TabletSYf51f7e6d-b132-48d8-8bb1-54203472f0d82
198024vitamin B3 500 MG Oral TabletSYf51f7e6d-b132-48d8-8bb1-54203472f0d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71741-020-307174100203030 TABLET in 1 BOTTLE (71741-020-30) 30 tablet2025-12-12NoNoCurrent
71741-020-607174100206060 TABLET in 1 BOTTLE (71741-020-60) 60 tablet2025-12-12NoNoCurrent
71741-020-907174100209090 TABLET in 1 BOTTLE (71741-020-90) 90 tablet2021-12-160000-00-00NoNoCurrent