FDA.reportPublic FDA data

Niacin

Product NDC
62175-320
11-digit product format
621750320
Labeler code
62175
Product ID
62175-320_7e9530d1-a940-42e8-b754-0d4089b39db1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
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
62175-320-43Niacin1000 in 1 BOTTLETABLET, EXTENDED RELEASE100016
62175-320-46Niacin90 in 1 BOTTLETABLET, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-320-46EA - Each62175-32066451a97-d51d-4e91-a3ba-b8db07fc2b7b12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-320NIACIN TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]15Current NDC, Legacy NDC, 2 package rows20250205_d7b66e13-00ed-48a9-a54a-8e474cc31d54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSNd7b66e13-00ed-48a9-a54a-8e474cc31d5416
1098141niacin 500 MG 24HR Extended Release Oral TabletPSNd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109813424 HR niacin 1000 MG Extended Release Oral TabletSCDd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109814124 HR niacin 500 MG Extended Release Oral TabletSCDd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109814124 HR vit-B3 500 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
1098141niacin 500 MG 24 HR Extended Release Oral TabletSYd7b66e13-00ed-48a9-a54a-8e474cc31d5416
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN8eff9205-84ac-e69d-e053-2995a90aad4b7
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN8eff9205-84ac-e69d-e053-2995a90aad4b7
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD8eff9205-84ac-e69d-e053-2995a90aad4b7
109814124 HR niacin 500 MG Extended Release Oral TabletSCD8eff9205-84ac-e69d-e053-2995a90aad4b7
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY8eff9205-84ac-e69d-e053-2995a90aad4b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-320-43621750320431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-320-43) 2017-02-160000-00-00NoNoCurrent
62175-320-466217503204690 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-320-46) 2017-02-160000-00-00NoNoCurrent