FDA.reportPublic FDA data

NIACIN

Product NDC
68180-222
11-digit product format
681800222
Labeler code
68180
Product ID
68180-222_309a40e8-333f-478a-8a94-beff7f3ca5b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIACIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090892
Marketing category
ANDA
Marketing start
2014-03-20
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
Rxcui1098134, 1098141, 1098143

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
68180-222-01NIACIN100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
68180-222-02NIACIN500 in 1 BOTTLETABLET, EXTENDED RELEASE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-222-01EA - Each68180-222a328f291-6646-4e5e-8e13-a9987dbccb1812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIACINACTIVE INGREDIENT2679MF687ANIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
NIACINACTIVE MOIETY2679MF687ANIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94ENIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-222NIACIN TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 2 package rows20231031_92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098134niacin 1000 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098141niacin 500 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098143niacin 750 MG 24HR Extended Release Oral TabletPSN92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR niacin 1000 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR niacin 500 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR niacin 750 MG Extended Release Oral TabletSCD92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR nicotinic acid 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR nicotinic acid 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR nicotinic acid 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR vit-B3 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR vit-B3 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR vit-B3 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109813424 HR vitamin B3 1000 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814124 HR vitamin B3 500 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
109814324 HR vitamin B3 750 MG Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098134niacin 1000 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098141niacin 500 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914
1098143niacin 750 MG 24 HR Extended Release Oral TabletSY92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-222-0168180022201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-222-01) 2014-03-200000-00-00NoNoCurrent
68180-222-0268180022202500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-222-02) 2014-03-200000-00-00NoNoCurrent