Atomoxetine (Page 9 of 9)

Package/Label Display Panel – Carton – 25 mg

25 mg Atomoxetine Capsules Carton
(click image for full-size original)

NDC 60687- 567 -21

Atomoxetine
Capsules, USP

25 mg

30 Capsules (3 x 10)                 Rx Only

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

Each Capsule Contains:
Atomoxetine hydrochloride USP equivalent to atomoxetine 25 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.

The drug product contained in this package is from
NDC # 64980-375, Rising Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

756721 0456721/0520

Package/Label Display Panel – Blister – 25 mg

25 mg Atomoxetine Capsule Blister
(click image for full-size original)

Atomoxetine Capsule, USP

25 mg

Package/Label Display Panel – Carton – 40 mg

40 mg Atomoxetine Capsules Carton
(click image for full-size original)

NDC 60687- 326 -25

Atomoxetine
Capsules, USP

40 mg

30 Capsules (5 x 6)            Rx Only

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

Each Capsule Contains:
Atomoxetine hydrochloride USP equivalent to
atomoxetine 40 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.

The drug product contained in this package is from
NDC # 64980-376, Rising Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

732625 0432625/0419OS

Package/Label Display Panel – Blister – 40 mg

40 mg Atomoxetine Capsule Blister
(click image for full-size original)

Atomoxetine Capsule, USP

40 mg

ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-567(NDC:64980-375)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
DIMETHICONE
SILICON DIOXIDE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color blue (Blue Opaque) , white (Off-white Opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code F;43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-567-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-567-11)
1 NDC:60687-567-11 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-567-21)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 07/29/2020
ATOMOXETINE atomoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-326(NDC:64980-376)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE) ATOMOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
DIMETHICONE
SILICON DIOXIDE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color blue (Blue Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code F;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-326-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-326-95)
1 NDC:60687-326-95 1 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-326-25)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079016 08/17/2017
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-326), repack (60687-567)

Revised: 06/2021 American Health Packaging

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