FDA.reportPublic FDA data

Niacin

Product NDC
65162-323
11-digit product format
651620323
Labeler code
65162
Product ID
65162-323_0b4acd9a-d32e-4727-a9c3-3754a375840c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Niacin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203578
Marketing category
ANDA
Marketing start
2015-07-27
Substance
NIACIN
Active strength
1000 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
NIACIN1000 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
65162-323-03Niacin30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
65162-323-09Niacin90 in 1 BOTTLETABLET, EXTENDED RELEASE9010
65162-323-50Niacin500 in 1 BOTTLETABLET, EXTENDED RELEASE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-323-09EA - Each65162-323b6e16ee6-0330-4f20-b578-c7d4fb3aa06f12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIACINACTIVE INGREDIENT2679MF687ANIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
NIACINACTIVE MOIETY2679MF687ANIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL45NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-323NIACIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 3 package rows20241031_6e604319-e164-4056-ab80-b78b98c519c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN6e604319-e164-4056-ab80-b78b98c519c710
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN6e604319-e164-4056-ab80-b78b98c519c710
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD6e604319-e164-4056-ab80-b78b98c519c710
109814124 HR niacin 500 MG Extended Release Oral TabletSCD6e604319-e164-4056-ab80-b78b98c519c710
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY6e604319-e164-4056-ab80-b78b98c519c710
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-323-036516203230330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-323-03) 2015-07-270000-00-00NoNoCurrent
65162-323-096516203230990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-323-09) 2015-07-270000-00-00NoNoCurrent
65162-323-5065162032350500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-323-50) 2015-07-270000-00-00NoNoCurrent