FDA.reportPublic FDA data

NIACIN

Product NDC
62135-497
11-digit product format
621350497
Labeler code
62135
Product ID
62135-497_456edffe-25de-6095-e063-6294a90a7d57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA203899
Marketing category
ANDA
Marketing start
2017-02-16
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
62135-497-90NIACIN90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-497-90EA - Each62135-4978318d725-9017-4a3c-a455-ebd4627c9bf712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-497NIACIN TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241025_568c3a99-b6e8-48b4-bb68-867bbcefa027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN568c3a99-b6e8-48b4-bb68-867bbcefa0273
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN568c3a99-b6e8-48b4-bb68-867bbcefa0273
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD568c3a99-b6e8-48b4-bb68-867bbcefa0273
109814124 HR niacin 500 MG Extended Release Oral TabletSCD568c3a99-b6e8-48b4-bb68-867bbcefa0273
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY568c3a99-b6e8-48b4-bb68-867bbcefa0273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-497-906213504979090 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-497-90) 2023-03-08NoNoCurrent