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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN500 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-584-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN1000 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-586-9090 in 1 BOTTLE Type 0: Not a Combination Product26/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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

label 1

AvKARE

NDC 42291-586-90

Niacin Extended-Release Tablets USP

1000 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 58690   1

label 1