FDA.reportPublic FDA data

Niacin

Product NDC
65162-322
11-digit product format
651620322
Labeler code
65162
Product ID
65162-322_b75c66ae-a08b-439c-b526-7897a38bc3a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204178
Marketing category
ANDA
Marketing start
2015-12-11
Substance
NIACIN
Active strength
750 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
NIACIN750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2679MF687A
Rxcui1098143

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
65162-322-03Niacin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3014
65162-322-09Niacin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9014
65162-322-50Niacin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-322-09EA - Each65162-32223651ed5-381e-4f5c-a7cd-764c124245bd12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-322NIACIN TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 3 package rows20241031_7250313b-b2ef-4736-bd25-2f29c2ac0eb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN7250313b-b2ef-4736-bd25-2f29c2ac0eb914
109814324 HR niacin 750 MG Extended Release Oral TabletSCD7250313b-b2ef-4736-bd25-2f29c2ac0eb914
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY7250313b-b2ef-4736-bd25-2f29c2ac0eb914
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY7250313b-b2ef-4736-bd25-2f29c2ac0eb914
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY7250313b-b2ef-4736-bd25-2f29c2ac0eb914
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY7250313b-b2ef-4736-bd25-2f29c2ac0eb914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-322-036516203220330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03) 2015-12-110000-00-00NoNoCurrent
65162-322-096516203220990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09) 2015-12-110000-00-00NoNoCurrent
65162-322-5065162032250500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-50) 2015-12-110000-00-00NoNoCurrent