NDC Code(s) : 0007-4640-13, 0007-4641-13, 0007-4641-61, 0007-4642-13, 0007-4643-13, 0007-4646-13, 0007-4515-27
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROMACTAeltrombopag olamine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code GS;NX3;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4640-1330 in 1 BOTTLE Type 0: Not a Combination Product24/11/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 11/24/2008 04/30/2019
PROMACTAeltrombopag olamine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG50 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code GS;UFU;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4641-1330 in 1 BOTTLE Type 0: Not a Combination Product24/11/2008
2NDC:0007-4641-6114 in 1 BOTTLE Type 0: Not a Combination Product24/11/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 11/24/2008 04/30/2019
PROMACTAeltrombopag olamine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG75 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code GS;FFS;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4642-1330 in 1 BOTTLE Type 0: Not a Combination Product01/05/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 01/05/2009 03/31/2019
PROMACTAeltrombopag olamine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4643
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG12.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code GS;FFS;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4643-1330 in 1 BOTTLE Type 0: Not a Combination Product01/02/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 01/02/2012 04/30/2019
PROMACTAeltrombopag olamine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4646
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG100 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GREEN Score no score
Shape ROUND (bi-convex) Size 10 mm
Flavor Imprint Code GS;1L5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4646-1330 in 1 BOTTLE Type 0: Not a Combination Product03/10/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 03/10/2014 11/28/2016
PROMACTAeltrombopag olamine POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-4515
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELTROMBOPAG OLAMINE(UNII: 4U07F515LG)
(ELTROMBOPAG - UNII:S56D65XJ9G) 		ELTROMBOPAG25 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color YELLOW (Reddish Brown to Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0007-4515-271 in 1 CARTON 27/11/2016
130 in 1 CARTON Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022291 11/27/2016 11/28/2016

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4643-13

PROMACTA®

(eltrombopag) Tablets

12.5 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag free acid.

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

GlaxoSmithKline, RTP, NC 27709

Made in Ireland

  •  10000000123247 Rev. 1/14
Promacta 12.5 mg 30 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4640-13

PROMACTA®

(eltrombopag) Tablets

25 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag free acid.

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

GlaxoSmithKline, RTP, NC 27709

Made in Ireland

  •  10000000123416 Rev. 1/14
Promacta 25mg 30 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4641-13

PROMACTA®

(eltrombopag) Tablets

50 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag free acid.

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

GlaxoSmithKline, RTP, NC 27709

Made in Ireland

  •  10000000123417 Rev. 1/14
Promacta 50mg 30 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4642-13

PROMACTA®

(eltrombopag) Tablets

75 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag free acid.

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

GlaxoSmithKline, RTP, NC 27709

Made in Ireland

  •  10000000123248 Rev. 1/14
Promacta 75mg 30 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4646-13

PROMACTA®

(eltrombopag) Tablets

100 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 100 mg of eltrombopag free acid.

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to77oF); excursions permitted to 15o to 30oC (59o to 86oF). Do not remove desiccant.

Do not use if printed safety seal under cap is broken or missing.

Dosage:

See accompanying prescribing information.

Important:

Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

GlaxoSmithKline, RTP, NC 27709

Made in Ireland

10000000123249 Rev. 1/14

Promacta 100mg 30 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0007-4514-27

PROMACTA®

(eltrombopag) for Oral Suspension

25 mg

Rx Only

Federal Law requires dispensing of PROMACTA® with the Medication Guide provided with this package.

30 Packets

©2015, the GSK group of companies

  •   DEVCOMP-0003801 Rev. 8/2015
Promacta 25mg oral suspension carton