Niacin

Product NDC
33342-187
11-digit product format
333420187
Labeler code
33342
Product ID
33342-187_2b583ae0-4d24-bd44-e063-6394a90a0ced
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204934
Marketing category
ANDA
Marketing start
2022-03-03
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
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
33342-187-10Niacin90 in 1 BOTTLETABLET904
33342-187-11Niacin100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-187-10EA - Each33342-187e4ef247a-b305-466e-b871-ae6f6494ae8212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-187NIACIN (NIACIN) TABLET [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20250112_52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109814124 HR niacin 500 MG Extended Release Oral TabletSCD52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-187-103334201871090 TABLET in 1 BOTTLE (33342-187-10) 90 tablet2022-03-030000-00-00NoNoCurrent
33342-187-1133342018711100 TABLET in 1 BOTTLE (33342-187-11) 100 tablet2022-03-030000-00-00NoNoCurrent