Prescription Drug Information: Niacin (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1
(click image for full-size original)

NDC 50268-584-13
Niacin Extended-Release Tablets
500 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026858413
NDC 50268-584-13
Niacin Extended-Release Tablets
500 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026858413
Pharmacist: Please dispense with Patient Information Leaflet provided separately.
Each film-coated extended-release tablet contains:
Niacin, USP…….. 500 mg
Usual Dosage: See package insert for full prescribing
information.
Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature].
KEEP THIS AND ALL MEDICATION OUT OF THE
REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A Product of AvKARE
Mfg. Rev. 07-2015-11
AV 09/17 (P) Niacin Extended-Release Tablets 500 mg Rx Only 30 Tablets (3 x 10) Unit Dose 5026858413

2
(click image for full-size original)

NDC 50268-586-13
Niacin Extended-Release Tablets
1000 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026858613
NDC 50268-586-13
Niacin Extended-Release Tablets
1000 mg
Rx Only
30 Tablets (3 x 10) Unit Dose
5026858613
Pharmacist: Please dispense with Patient Information
Leaflet provided separately.
Each film-coated extended-release tablet contains:
Niacin, USP ………………………………………. 1000 mg
Usual Dosage: See package insert for full prescribing
information.
Store at 20° to 25°C (68° to 77°F) [See USP
Controlled Room Temperature].
KEEP THIS AND ALL MEDICATION OUT OF THE
REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A Product of AvKARE
Mfg. Rev. 07-2015-01 AV 09/17 (P)

NIACIN niacin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-584(NDC:65162-321)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN (NIACIN) NIACIN 500 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 400
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;321
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-584-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-584-11)
1 NDC:50268-584-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-584-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203578 09/14/2017
NIACIN niacin tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-586(NDC:65162-323)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACIN (NIACIN) NIACIN 1000 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 400
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AN;323
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-586-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-586-11)
1 NDC:50268-586-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-586-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203578 09/14/2017 09/30/2021
Labeler — AvPAK (832926666)

Revised: 10/2021 AvPAK

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