NDC Code(s) : 0093-7392-98, 0093-7392-86, 0093-7393-98, 0093-7393-86, 0093-7394-98, 0093-7394-86
Packager : Teva Pharmaceuticals USA, 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: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:0093-7392-9890 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
2NDC:0093-7392-86180 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076378 09/20/2013 11/30/2018
NiacinNiacin TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7393
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN750 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;213;750
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-7393-9890 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
2NDC:0093-7393-86180 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076378 09/20/2013 09/30/2018
NiacinNiacin TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:0093-7394-9890 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
2NDC:0093-7394-86180 in 1 BOTTLE Type 0: Not a Combination Product20/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076250 09/20/2013 01/31/2019

PRINCIPAL DISPLAY PANEL

Niacin Extended-Release Tablets USP 500 mg 90s Label

PRINCIPAL DISPLAY PANEL

Niacin Extended-Release Tablets USP 750 mg 90s Label

PRINCIPAL DISPLAY PANEL

Niacin Extended-Release Tablets USP 1000 mg 90s Label