NDC Code(s) : 68084-877-95, 68084-877-25
Packager : American Health Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Candesartan cilexetilCandesartan cilexetil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-877(NDC:0781-5938)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDESARTAN CILEXETIL(UNII: R85M2X0D68)
(CANDESARTAN - UNII:S8Q36MD2XX) 		CANDESARTAN CILEXETIL16 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 7 mm
Flavor Imprint Code M;C;31
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-877-2530 in 1 BOX, UNIT-DOSE 30/09/2015
1NDC:68084-877-951 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078702 09/01/2015 01/31/2017

PRINCIPAL DISPLAY PANEL

Candesartan Cilexetil 16 mg Label (5 x 6)

NDC 68084-877-25

Candesartan Cilexetil
Tablets

16 mg

30 Tablets (5 x 6)

PHARMACIST: Dispense the accompanying
Patient Information Leaflet to each patient.

Each Tablet Contains:
Candesartan cilexetil, USP…………………16 mg

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.

Rx Only

The drug product contained in this package is from
NDC # 0781-5938, Sandoz Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

087725
Rev. 07/2015OS