NDC Code(s) : 86026-001-21, 86026-001-23, 86026-001-26, 86026-002-21, 86026-002-23, 86026-002-26, 86026-003-21, 86026-003-23, 86026-003-26
Packager : Aratana Therapeutics, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Galliprantgrapiprant TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:86026-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
grapiprant(UNII: J9F5ZPH7NB)
(grapiprant - UNII:J9F5ZPH7NB)
grapiprant20 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape OVAL (OVAL) Size 12 mm
Flavor Imprint Code 20;mg;G;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:86026-001-2148 in 1 BOX
11 in 1 CARTON
17 in 1 BOTTLE
2NDC:86026-001-2348 in 1 BOX
21 in 1 CARTON
230 in 1 BOTTLE
3NDC:86026-001-2648 in 1 BOX
31 in 1 CARTON
390 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141455 01/03/2016
Galliprantgrapiprant TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:86026-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
grapiprant(UNII: J9F5ZPH7NB)
(grapiprant - UNII:J9F5ZPH7NB)
grapiprant60 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape OVAL (OVAL) Size 18 mm
Flavor Imprint Code 60;mg;G;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:86026-002-2148 in 1 BOX
11 in 1 CARTON
17 in 1 BOTTLE
2NDC:86026-002-2348 in 1 BOX
21 in 1 CARTON
230 in 1 BOTTLE
3NDC:86026-002-2648 in 1 BOX
31 in 1 CARTON
390 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141455 01/03/2016
Galliprantgrapiprant TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:86026-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
grapiprant(UNII: J9F5ZPH7NB)
(grapiprant - UNII:J9F5ZPH7NB)
grapiprant100 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape OVAL (OVAL) Size 100 mm
Flavor Imprint Code 100;mg;G;G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:86026-003-2148 in 1 BOX
11 in 1 CARTON
17 in 1 BOTTLE
2NDC:86026-003-2348 in 1 BOX
21 in 1 CARTON
230 in 1 BOTTLE
3NDC:86026-003-2648 in 1 BOX
31 in 1 CARTON
390 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141455 01/03/2016

PRINCIPAL DISPLAY PANEL

NDC 86026-001-21

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by
or on the order of a
licensed veterinarian.

7 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-001-21

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by or on
the order of a licensed veterinarian.

7 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-21

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by
or on the order of a
licensed veterinarian.

7 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-21

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by or on
the order of a licensed veterinarian.

7 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-21

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law restricts
this drug to use by or on the order
of a licensed veterinarian.

7 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-21

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.

7 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-001-23

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by
or on the order of a
licensed veterinarian.

30 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-001-23

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by or on
the order of a licensed veterinarian.

30 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-23

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law restricts
this drug to use by or on the order
of a licensed veterinarian.

30 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-23

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.

30 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-23

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law
restricts this drug to use by or on
the order of a licensed veterinarian.

30 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-23

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.

30 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-001-26

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law restricts
this drug to use by or on the order
of a licensed veterinarian.

90 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-001-26

Galliprant®
(grapiprant tablets)

20 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.

90 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 20 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-26

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law restricts
this drug to use by or on the order
of a licensed veterinarian.

90 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-002-26

Galliprant®
(grapiprant tablets)

60 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to use by or
on the order of a licensed veterinarian.

90 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 60 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-26

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor
Antagonist NSAID

Caution: Federal (USA) law restricts
this drug to use by or on the order
of a licensed veterinarian.

90 Flavored
Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Carton Label

PRINCIPAL DISPLAY PANEL

NDC 86026-003-26

Galliprant®
(grapiprant tablets)

100 mg

For oral use in dogs only

EP4 Prostaglandin Receptor Antagonist NSAID

Caution: Federal (USA) law restricts this drug to use by or
on the order of a licensed veterinarian.

90 Flavored Tablets

NADA 141-455

Approved by FDA

ARATANA
THERAPEUTICS®

Principal Display Panel - Galliprant 100 mg Bottle Label