FDA.reportPublic FDA data

Niacin

Product NDC
50268-584
11-digit product format
502680584
Labeler code
50268
Product ID
50268-584_4ba8c8c4-810e-b1f2-e063-6394a90a2d32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA203578
Marketing category
ANDA
Marketing start
2017-09-14
Substance
NIACIN
Active strength
500 mg/1
Pharmacologic classes
Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Niacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2679MF687A
Rxcui1098134, 1098141

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
50268-584-11Niacin1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE18
50268-584-13Niacin30 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-584-11EA - Each50268-584a5653c65-74f6-49ee-99f7-448e2871c79212018-03-08
50268-584-13EA - Each50268-584d2198ff2-b718-4aa0-9238-386102a1eb3212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-584NIACIN TABLET, EXTENDED RELEASE [AVPAK]6Current NDC, Legacy NDC, 2 package rows20240110_dd60fe81-3d54-4a29-9502-601be89c575e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSNdd60fe81-3d54-4a29-9502-601be89c575e8
1098141niacin 500 MG 24HR Extended Release Oral TabletPSNdd60fe81-3d54-4a29-9502-601be89c575e8
109813424 HR niacin 1000 MG Extended Release Oral TabletSCDdd60fe81-3d54-4a29-9502-601be89c575e8
109814124 HR niacin 500 MG Extended Release Oral TabletSCDdd60fe81-3d54-4a29-9502-601be89c575e8
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
109814124 HR vit-B3 500 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8
1098141niacin 500 MG 24 HR Extended Release Oral TabletSYdd60fe81-3d54-4a29-9502-601be89c575e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-584-11502680584111 in 1 BLISTER PACKHistorical
50268-584-135026805841330 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11) 30 blister pack2017-09-140000-00-00NoNoCurrent