NDC Code 42291-586-90 - Niacin

NDC Code(s) : 42291-584-90, 42291-586-90
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NiacinNiacin TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42291-584(NDC:0093-7392)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIACIN(UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	500 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
POVIDONE K90(UNII: RDH86HJV5Z)
STEARIC ACID(UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL (capsule-shaped)	Size	18 mm
Flavor		Imprint Code	b;212;500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42291-584-90	90 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076378	08/26/2016

NiacinNiacin TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42291-586(NDC:0093-7394)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIACIN(UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	1000 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE 2910 (10000 MPA.S)(UNII: 0HO1H52958)
POVIDONE K90(UNII: RDH86HJV5Z)
STEARIC ACID(UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	OVAL (capsule-shaped)	Size	19 mm
Flavor		Imprint Code	b;214;1000
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42291-586-90	90 in 1 BOTTLE Type 0: Not a Combination Product	26/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076250	08/26/2016

PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-584-90

Niacin Extended-Release Tablets USP

500 mg

Once-Daily at Bedtime

90 Tablets Rx Only

PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

Each extended-release tablet contains 500 mg niacin, USP.

Usual Dosage: See package insert for full prescribing information.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Keep out of reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 04/15 AV 08/16 (P)

N3 42291 58490 7