Varenicline (Page 12 of 12)

Package/Label Display Panel – Carton – 1 mg

NDC 60687- 648 -21

Varenicline
Tablets

1 mg

30 Tablets (3 x 10)                 Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
1.71 mg varenicline tartrate equivalent to 1 mg varenicline free
base.

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 49884-156, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

764821 0464821/1221

Package/Label Display Panel – Blister – 1 mg

Varenicline Tablet

1 mg

VARENICLINE varenicline tartrate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-648(NDC:49884-156) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VARENICLINE TARTRATE (VARENICLINE) VARENICLINE 1 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM MALTODEXTRIN MICROCRYSTALLINE CELLULOSE STEARIC ACID HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE 2910 (6 MPA.S) TALC TITANIUM DIOXIDE FD&C BLUE NO. 2 FERRIC OXIDE YELLOW

Product Characteristics Color blue (light blue) Score no score Shape ROUND (circular, biconvex) Size 9mm Flavor Imprint Code P;156 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60687-648-21 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (60687-648-11) 1 NDC:60687-648-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60687-648-21)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201785 02/01/2022

Labeler — American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Operations
American Health Packaging		929561009	repack (60687-648)

Revised: 01/2022 American Health Packaging